production - food and drug administration · drug facts text defined • headings •...

Madison Artwork & Packaging CenterOne Giralda Farms, Madison, NJ 07940Phone: (973) 660-5000

Date 21-OCT-2016 PASS # 1Component # PAA076833Drawing # DWG-00000785v02

Madison Artwork & Packaging CenterGraphic Artist:

PRINTER TO REPLACE ALL FPO CODESWITH SCANNABLE ART.

PRINTER RESPONSIBLE FOR ALLTRAPPING, BLEEDS, COATINGS AND RESOLUTION.PRINTER AND USERS RESPONSIBLE FOR PROPER

LICENSING OF ALL FONTS USED IN THIS ARTWORK.

Job Information

Identi�cation

Color Legend

Vendor Identi�cation

Printer & User Notes

PRODUCTION (NOT COLOR ACCURATE)

See Art For Colors

DRUG FACTS TEXT DEFINED

• HEADINGS

• SUBHEADINGS/BODY TEXT

• LEADING

• BULLETS

• SPACE BEFORE BULLET

• WARNING BOX LINE, HAIRLINES

TYPE SIZE

6 pt

6 pt

6.35 pt

5 pt

2 ems

.5 pt

Solubilized Ibuprofen, 200 mg / Diphenhydramine HCl, 25 mg Pain Reliever (NSAID) /Nighttime Sleep-Aid


Liquid F lledCapsules

Liquid F lledCapsules

2020

LIFT

HER

E

For M

ore

Drug Fa

cts

PAA076833

Uses � for relief of occasional sleeplessness when associated with minor aches and pains� helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over, taking any other drug or have stomach problems.

� This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away.

� Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine. � Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed. � Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. � When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks.

Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718

Do Not Use if seal under bottle cap imprinted with“SEALED for YOUR PROTECTION” is broken or missing.

READ AND KEEP CARTON FOR COMPLETEWARNINGS AND INFORMATION

RELEASED BACKPANEL 2

3/8" HINGE AREAUNVARNISHED

KISS CUT


TOPPANEL 1

BASEPANEL 3

3/16" X 3/16" DATA MATRIX CODE (ECC 200), PRINTED IN BLACK OR DARK BLUE ON UNPRINTED WHITE BACKGROUND.DATA MATRIX CODE = 076833

UNVARNISHED AND PRINTED IN BLACK OR DARK BLUE FOR LOT & EXPIRATION AREA.

0901

77e1

8affa

fd6\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

22

Reference ID: 4076493

(b) (4)

(b) (4)

(b) (4)

(b) (4)

DRUG FACTS MODIFIED TEXT DEFINED

• DRUG FACTS TITLE

• DRUG FACTS CONTINUED

• HEADINGS


• LEADING

• # OF CHARACTERS PER INCH

• BULLETS


• BARLINES, HAIRLINES

• SPACE BETWEEN HAIRLINES AND BOX END

TYPE SIZE

8 pt

7 pt

7 pt

6 pt

6.25 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces

EmbossingFull size file on Emboss layer

Embossing - 2nd levelFull size file on Emboss layer

Silver Foil StampFull size file on Silver Foil layer


Date 26-OCT-2016 PASS #1Component # PAA076834Drawing # DWG-00001042 v04

Madison Artwork & Packaging CenterGraphic Artist




Job Information

Identi�cation

Color Legend



(NOT COLOR ACCURATE)PRODUCTIONPrinter Notes:FPO Silver Foil is only representative of Foil Stamp. Do not separate or print.

Solubilized Ibuprofen, 200 mg / Diphenhydramine HCl, 25 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid


2020Liquid Filled

CapsulesLiquid Filled

Capsules

076834

076834 0768

34

0768

34

FPO

3 0573 0167 25 3

PAA076834

Drug FactsActive ingredients (in each capsule)

PurposesDiphenhydram

ine hydrochloride 25 mg..Nighttim

e sleep-aid Solubilized ibuprofen equal to 200 m

g ibuprofen (NSAID)*............................Pain reliever(present as the free acid and potassium

salt)* nonsteroidal anti-inflam

matory drug

Uses � for relief of occasional sleeplessness when

associated with minor aches and pains �

helps you fall asleep and stay asleep

Warnings

Allergy alert: Ibuprofen may cause a severe allergic

reaction, especially in people allergic to aspirin. Sym

ptoms m

ay include: �

hives � facial swelling �

asthma (wheezing)

� shock �

skin reddening � rash �

blistersIf an allergic reaction occurs, stop use and seek m

edical help right away.Stom

ach bleeding warning: This product contains an NSAID, which m

ay cause severe stomach bleeding. The

chance is higher if you � are age 60 or older �

have had stom

ach ulcers or bleeding problems �

take a blood thinning (anticoagulant) or steroid drug �

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] �

have 3 or m

ore alcoholic drinks every day while using this product �

take more or for a longer tim

e than directed

Drug Facts (continued)Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use m

ore than directed or for longer than directed.Do not use �

if you have ever had an allergic reaction to any other pain reliever/fever reducer �

unless you have time for

a full night's sleep � in children under 12 years of age

� right before or after heart surgery �

with any other product containing diphenhydram

ine, even one used on skin �

if you have sleeplessness without painAsk a doctor before use if �

stomach bleeding warning

applies to you � you have problem

s or serious side effects from

taking pain relievers or fever reducers � you have a

history of stomach problem

s, such as heartburn � you have

high blood pressure, heart disease, liver cirrhosis, kidney disease, asthm

a, or had a stroke � you are taking a diuretic

� you have a breathing problem

such as emphysem

a or chronic bronchitis �

you have glaucoma �

you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharm

acist before use if you are�

taking sedatives or tranquilizers, or any other sleep-aid�

under a doctor’s care for any continuing medical illness

� taking any other antihistam

ines � taking aspirin for heart

attack or stroke, because ibuprofen may decrease this benefit

of aspirin � taking any other drug

When using this product �

drowsiness will occur � avoid

alcoholic drinks � do not drive a m

otor vehicle or operatem

achinery � take with food or m

ilk if stomach upset occurs

Drug Facts (continued)Stop use and ask a doctor if �

you experience any of the following signs of stom

ach bleeding: � feel faint

� vom

it blood � have bloody or black stools �

have stom

ach pain that does not get better �

you have symptom

s of heart problems or stroke:

�

chest pain �

trouble breathing

� weakness in one part or side of body

�

slurred speech � leg swelling

� pain gets worse or lasts m

ore than 10 days �

sleeplessness persists continuously for more than

2 weeks. Insomnia m

ay be a symptom

of a serious underlying m

edical illness. � redness or swelling is

present in the painful area � any new sym

ptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially im

portant not to use ibuprofen during the last 3 m

onths of pregnancy unless definitely directed to do so by a doctor because it m

ay cause problem

s in the unborn child or complications during

delivery. Keep out of reach of children. In case of overdose, get m

edical help or contact a Poison Control Center right away.

Directions � do not take m

ore than directed �

adults and children 12 years and over: take 2 capsules at bedtim

e � do not take m

ore than 2 capsules in 24 hours

Other information �

each capsule contains: potassium

20 mg �

read all warnings and directions before use. Keep carton. �

store at 20-25°C (68-77°F)

Drug Facts (continued)� avoid excessive heat above 40°C (104°F) � protect from light

Inactive ingredients D&C red no. 33, FD&C blue no. 1, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

For most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA

© 2016 Pfizer Inc. U.S. Patent 9,155,718LIQUI-GELS® is a trademark or registered trademark

of Catalent Pharma Solutions.


PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

TLA

SE

R C

OD

ING

(V

AR

NIS

HE

D)

UN

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

T(U

NV

AR

NIS

HE

D)

128

CO

DE

AR

EA

- S

UB

SE

T C

10

MIL

DE

NS

ITY

WIT

H 4

OR

6 D

IGIT

S (

CO

DE

TO

EX

TE

ND

TO

ED

GE

OF

FLA

P -

UN

VA

RN

ISH

ED

)P

RIN

TE

D S

IDE

OF

CA

RT

ON

UNVARNISHED AREAS

0901

77e1

8a9c

102c

\Fin

al\F

inal

On:

18-

Nov

-201

6 18

:20


(b) (4)

(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

6 pt

6 pt

6.35 pt

5 pt

2 ems

.5 pt


Date 07-NOV-2016 PASS # 1Component # PAA077332Drawing # DWG-00000785v02





Job Information

Identi�cation

Color Legend




See Art For Colors



Liquid FilledCapsules


3030

Uses � for relief of occasional sleeplessness when associated with minor aches and pains � helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over,

taking any other drug or have stomach problems. � This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away.

� Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine. � Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed. � Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. � When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks.

Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718


READ AND KEEP CARTON FOR COMPLETEWARNINGS AND INFORMATION LI

FT H

ERE

For M

ore

Drug Fa

cts

PAA077332

RELEASED BACKPANEL 2


KISS CUT


TOPPANEL 1

BASEPANEL 3



0901

77e1

8affa

fda\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

26


(b) (4)

(b) (4)

(b) (4)

(b) (4)




• HEADINGS


• LEADING


• BULLETS




TYPE SIZE

8 pt

7 pt

7 pt

6 pt

6.25 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces


Date 09-NOV-2016 PASS # 1Component # PAA077331Drawing # DWG-00001042 v04





Job Information

Identi�cation

Color Legend



(NOT COLOR ACCURATE)

Embossing - # 1Full size file on Emboss layer

Embossing - 2nd level SculpturedFull size file on Emboss layer


PRODUCTION

Printer Notes:FPO Silver Foil is only representative of Foil Stamp. Do not separate or print.




3020

FPO

3 0573 0167 26 0

PAA077331





ine hydrochloride 25 mg..Nighttim

e sleep-aid Solubilized ibuprofen equal to 200 m

g ibuprofen (NSAID)*............................Pain reliever(present as the free acid and potassium

salt)* nonsteroidal anti-inflam

matory drug

Uses � for relief of occasional sleeplessness when

associated with minor aches and pains �


Warnings



ptoms m

ay include: �

hives � facial swelling �

asthma (wheezing)

� shock �

skin reddening � rash �




ay cause severe stomach bleeding. The

chance is higher if you � are age 60 or older �

have had stom

ach ulcers or bleeding problems �

take a blood thinning (anticoagulant) or steroid drug �

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] �

have 3 or m

ore alcoholic drinks every day while using this product �

take more or for a longer tim

e than directed


ore than directed or for longer than directed.Do not use �

if you have ever had an allergic reaction to any other pain reliever/fever reducer �

unless you have time for

a full night's sleep � in children under 12 years of age

� right before or after heart surgery �

with any other product containing diphenhydram

ine, even one used on skin �

if you have sleeplessness without painAsk a doctor before use if �

stomach bleeding warning

applies to you � you have problem

s or serious side effects from

taking pain relievers or fever reducers � you have a

history of stomach problem

s, such as heartburn � you have

high blood pressure, heart disease, liver cirrhosis, kidney disease, asthm

a, or had a stroke � you are taking a diuretic

� you have a breathing problem

such as emphysem

a or chronic bronchitis �

you have glaucoma �

you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharm

acist before use if you are�

taking sedatives or tranquilizers, or any other sleep-aid�

under a doctor’s care for any continuing medical illness

� taking any other antihistam

ines � taking aspirin for heart

attack or stroke, because ibuprofen may decrease this benefit

of aspirin � taking any other drug

When using this product �

drowsiness will occur � avoid

alcoholic drinks � do not drive a m

otor vehicle or operatem

achinery � take with food or m


Drug Facts (continued)Stop use and ask a doctor if �


ach bleeding: � feel faint

� vom

it blood � have bloody or black stools �

have stom

ach pain that does not get better �

you have symptom


�

chest pain �

trouble breathing


�



ore than 10 days �


2 weeks. Insomnia m

ay be a symptom


edical illness. � redness or swelling is

present in the painful area � any new sym

ptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially im



ay cause problem

s in the unborn child or complications during

delivery. Keep out of reach of children. In case of overdose, get m

edical help or contact a Poison Control Center right away.


ore than directed �


e � do not take m

ore than 2 capsules in 24 hours

Other information �

each capsule contains: potassium

20 mg �

read all warnings and directions before use. Keep carton. �

store at 20-25°C (68-77°F)

Drug Facts (continued)� avoid excessive heat above 40°C (104°F) � protect from light






FREEMORE50%

®10 Free

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

TLA

SE

R C

OD

ING

(V

AR

NIS

HE

D)

UN

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

T(U

NV

AR

NIS

HE

D)

128

CO

DE

AR

EA

- S

UB

SE

T C

10

MIL

DE

NS

ITY

WIT

H 4

OR

6 D

IGIT

S (

CO

DE

TO

EX

TE

ND

TO

ED

GE

OF

FLA

P -

UN

VA

RN

ISH

ED

)P

RIN

TE

D S

IDE

OF

CA

RT

ON

077331

077331 0773

31

0773

31

0901

77e1

8affb

faf\F

inal

\Fin

al O

n: 0

6-Ja

n-20

17 2

1:25


(b) (4)

(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

5.3 pt

5.3 pt

5.8 pt

4.3 pt

2 ems

.5 pt


Date 20-OCT-2016 PASS # 1Component # PAA076835Drawing # DWG-00000433v01





Job Information

Identi�cation

Color Legend






4040Liquid Filled


Capsules


Uses� for relief of occasional sleeplessness when associated with minor aches and pains� helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over, taking any other drug or have stomach problems. � This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an a lergic reaction occurs, stop use and seek medical help right away. � Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine.

� Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed.� Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.� When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks. Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR

PROTECTION” is broken or missing.

PAA076835

3/16" X 3/16" DATA MATRIX CODE (ECC200),PRINTED IN BLACK OR DARK BLUE ONUNPRINTED WHITE BACKGROUND.DATA MATRIX CODE = 076835

UNVARNISHED AND PRINTED IN BLACK OR DARK BLUE. FOR LOT & EXPIRATION AREA.

0901

77e1

8affa

fd9\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

22


(b) (4)

(b) (4)





• HEADINGS


• LEADING


• BULLETS




TYPE SIZE

8 pt

7 pt

7 pt

6 pt

6.25 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces

Emboss - #2 sculpturedFull size file on Emboss layer

Emboss #1Full size file on Emboss layer



Date 30-JAN-2017 PASS # 1Component # PAA085164Drawing # DWG-00000432v04





Job Information

Identi�cation

Color Legend






4040Liquid Filled


Capsules

FPO 128 Code085164

FPO 128 Code085164

FPO

128

Code

0851

64

FPO

128

Code

0851

6430573 0167 43

7PAA085164




READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORM

ATION



WARNINGS AND INFORM

ATION



ine hydrochloride 25 m

g...............................Nighttime sleep-aid

Solubilized ibuprofen equal to 200 m

g ibuprofen (NSAID)*..............................Pain reliever(present as the free acid and potassium

salt)*nonsteroidal anti-inflam

matory drug

Uses�

for relief of occasional sleeplessness when associated with m

inor aches and pains�


Warnings



ptoms m

ay include: �

hives �

facial swelling �

asthma (wheezing)

� shock

� skin reddening

� rash �




ay cause severe stomach bleeding.

The chance is higher if you �

are age 60 or older�

have had stomach ulcers or bleeding problem

s�

take a blood thinning (anticoagulant) or steroid drug�

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

� have 3 or m

ore alcoholic drinks every day while using this product

� take m

ore or for a longer time than directed


ore than directed or for longer than directed.Do not use�

if you have ever had an allergic reaction to any other pain reliever/fever reducer

� unless you have tim

e for a full night's sleep �

in children under 12 years of age�

right before or after heart surgery �

with any other product containing diphenhydramine, even

one used on skin �

if you have sleeplessness without painAsk a doctor before use if�

stomach bleeding warning applies to you

� you have problem

s or serious side effects from taking

pain relievers or fever reducers �

you have a history of stomach problem

s, such as heartburn

� you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthm

a, or had a stroke �

you are taking a diuretic �

you have a breathing problem such as em

physema or

chronic bronchitis �

you have glaucoma

� you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

� taking sedatives or tranquilizers, or any other sleep-aid

� under a doctor’s care for any continuing m

edical illness �

taking any other antihistamines

� taking aspirin for heart attack or stroke, because ibuprofen m

ay decrease this benefit of aspirin �

taking any other drugW

hen using this product�

drowsiness will occur � avoid alcoholic drinks

� do not drive a m

otor vehicle or operate machinery

� take with food or m


Drug Facts (continued)Stop use and ask a doctor if�


ach bleeding:�

feel faint � vom

it blood � have bloody or black stools

� have stom

ach pain that does not get better�

you have symptom


�

chest pain �

trouble breathing


�



ore than 10 days�


2 weeks. Insomnia m

ay be a symptom


edical illness. �

redness or swelling is present in the painful area �

any new symptom

s appearIf pregnant or breast-feeding, ask a health professional before use. It is especially im



ay cause problems in the unborn child

or complications during delivery.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.


ore than directed�


e �

do not take more than 2 capsules in 24 hours

Other information

� each capsule contains: potassium

20 mg

� read all warnings and directions before use. Keep carton.

� store at 20-25°C (68-77°F)

� avoid excessive heat above 40°C (104°F)

� protect from

light

Inactive ingredients D&C red no. 33, FD&C blue no. 1, gelatin, m

edium-chain triglycerides, pharm

aceutical ink, polyethylene glycol, potassium

hydroxide, purified water, sorbitol sorbitan solution

Drug Facts (continued)Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

TLA

SE

R C

OD

ING

(V

AR

NIS

HE

D)

UN

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

T(U

NV

AR

NIS

HE

D)

128

CO

DE

AR

EA

- S

UB

SE

T C

10

MIL

DE

NS

ITY

WIT

H 4

OR

6 D

IGIT

S (

CO

DE

TO

EX

TE

ND

TO

ED

GE

OF

FLA

P -

UN

VA

RN

ISH

ED

)P

RIN

TE

D S

IDE

OF

CA

RT

ON

UNVARNISHED AREAS

0901

77e1

8b34

f350

\Fin

al\F

inal

On:

06-

Feb

-201

7 16

:43

(GM

T)


(b) (4)

(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

5.25 pt

5.25 pt

5.55 pt

4.25 pt

2 ems

.5 pt







Job Information

Identi�cation

Color Legend






5050Liquid Filled


Capsules



Uses� for relief of occasional sleeplessness when associated with minor aches and pains � helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over, taking any other drug or have stomach problems. � This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. � Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine.

� Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed.� Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.� When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks. Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F)Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718

PAA077260

3/16" X 3/16" DATA MATRIX CODE (ECC200),PRINTED IN BLACK OR DARK BLUE ONUNPRINTED WHITE BACKGROUND.DATA MATRIX CODE = 077260

UNVARNISHED AND PRINTED IN BLACK OR DARK BLUE. FOR LOT & EXPIRATION AREA.

5-1/2"

2"

0901

77e1

8affc

236\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

25


(b) (4)

(b) (4)



Date 08-NOV-2016 PASS # 1Component # PAA077259Drawing # DWG-00000432 v04





Job Information

Identi�cation

Color Legend







• HEADINGS


• LEADING


• BULLETS




TYPE SIZE

8 pt

7 pt

7 pt

6 pt

6.25 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces

Emboss - #2 sculpturedFull size file on Emboss layer

Emboss #1Full size file on Emboss layer


FPO 128 Code077259

FPO 128 Code077259

FPO

128

Code

0772

59

FPO

128

Code

0772

5930573 0167 44

4PAA077259





WARNINGS AND INFORM

ATION



WARNINGS AND INFORM

ATION



ine hydrochloride 25 m

g...............................Nighttime sleep-aid

Solubilized ibuprofen equal to 200 m

g ibuprofen (NSAID)*..............................Pain reliever(present as the free acid and potassium

salt)*nonsteroidal anti-inflam

matory drug

Uses�

for relief of occasional sleeplessness when associated with m

inor aches and pains�


Warnings



ptoms m

ay include: �

hives �

facial swelling �

asthma (wheezing)

� shock

� skin reddening

� rash �




ay cause severe stomach bleeding.

The chance is higher if you �

are age 60 or older�

have had stomach ulcers or bleeding problem

s�

take a blood thinning (anticoagulant) or steroid drug�

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

� have 3 or m

ore alcoholic drinks every day while using this product

� take m

ore or for a longer time than directed


ore than directed or for longer than directed.Do not use�

if you have ever had an allergic reaction to any other pain reliever/fever reducer

� unless you have tim

e for a full night's sleep �

in children under 12 years of age�

right before or after heart surgery �

with any other product containing diphenhydramine, even

one used on skin �

if you have sleeplessness without painAsk a doctor before use if�

stomach bleeding warning applies to you

� you have problem

s or serious side effects from taking

pain relievers or fever reducers �

you have a history of stomach problem

s, such as heartburn

� you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthm

a, or had a stroke �

you are taking a diuretic �

you have a breathing problem such as em

physema or

chronic bronchitis �

you have glaucoma

� you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

� taking sedatives or tranquilizers, or any other sleep-aid

� under a doctor’s care for any continuing m

edical illness �

taking any other antihistamines

� taking aspirin for heart attack or stroke, because ibuprofen m

ay decrease this benefit of aspirin �

taking any other drugW

hen using this product�

drowsiness will occur � avoid alcoholic drinks

� do not drive a m

otor vehicle or operate machinery

� take with food or m


Drug Facts (continued)Stop use and ask a doctor if�


ach bleeding:�

feel faint � vom

it blood � have bloody or black stools

� have stom

ach pain that does not get better�

you have symptom


�

chest pain �

trouble breathing


�



ore than 10 days�


2 weeks. Insomnia m

ay be a symptom


edical illness. �

redness or swelling is present in the painful area �

any new symptom

s appearIf pregnant or breast-feeding, ask a health professional before use. It is especially im



ay cause problems in the unborn child

or complications during delivery.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.


ore than directed�


e �

do not take more than 2 capsules in 24 hours

Other information

� each capsule contains: potassium

20 mg

� read all warnings and directions before use. Keep carton.

� store at 20-25°C (68-77°F)

� avoid excessive heat above 40°C (104°F)

� protect from

light

Inactive ingredients D&C red no. 33, FD&C blue no. 1, gelatin, m

edium-chain triglycerides, pharm

aceutical ink, polyethylene glycol, potassium

hydroxide, purified water, sorbitol sorbitan solution

Drug Facts (continued)Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL



5040Liquid Filled

Capsules

FREEMORE25%

10 Free®

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

TLA

SE

R C

OD

ING

(V

AR

NIS

HE

D)

UN

PR

INT

ED

AR

EA

FO

R D

AT

E &

LO

T(U

NV

AR

NIS

HE

D)

128

CO

DE

AR

EA

- S

UB

SE

T C

10

MIL

DE

NS

ITY

WIT

H 4

OR

6 D

IGIT

S (

CO

DE

TO

EX

TE

ND

TO

ED

GE

OF

FLA

P -

UN

VA

RN

ISH

ED

)P

RIN

TE

D S

IDE

OF

CA

RT

ON

UNVARNISHED AREAS

0901

77e1

8affb

fb0\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

25


(b) (4)

(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

5.5 pt

5.5 pt

6 pt

4.5 pt

2 ems

.5 pt


Date 28-SEP-2016 PASS # 2Component # PAA080265Drawing # DWG-00000507 v02





Job Information

Identi�cation

Color Legend






8080Liquid Filled


Capsules


Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Uses � for relief of occasional sleeplessness when associated with minor aches and pains � helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over, taking any other drug or have stomach problems. � This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. � Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine. � Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. � When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks. Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.com Distributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718

PAA080265



0901

77e1

89bc

f0a0

\Fin

al\F

inal

On:

29-

Sep

-201

6 02

:05

Reference 6493

(b) (4)

(b) (4)

Silver Foil StampFull size file on Silver Foil layerMust open file with Illustrator

Embossing #2 sculpturedFull size file on Emboss #2 layerMust open file with Illustrator


Embossing #1Full size file on Emboss #1 layerMust open file with Illustrator




• HEADINGS


• LEADING


• BULLETS




TYPE SIZE

9.0 pt

8.0 pt

8.0 pt

6.0 pt

6.5 pt

<39

5.0 pt

2 ems

1.5 pt, .5 pt

2 spaces


Date 22-SEP-2016 PASS # 1Component # PAA080264Drawing # DWG-00000431v01





Job Information

Identi�cation

Color Legend




GreatValue





8080Liquid Filled


Capsules

FPO 128 Code080264

FPO 128 Code080264

FPO 128 Code080264

FPO 128 Code080264

3 0573 0167 55 0

PAA080264


Drug FactsActive ingredients (in each capsule) PurposesDiphenhydramine hydrochloride 25 mg................................... Nighttime sleep-aidSolubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*...................................Pain reliever(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Uses� for relief of occasional sleeplessness when associated with

minor aches and pains� helps you fall asleep and stay asleep

WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: � hives � facial swelling � asthma (wheezing)� shock � skin reddening � rash � blistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older� have had stomach ulcers or bleeding problems� take a blood thinning (anticoagulant) or steroid drug� take other drugs containing prescription or nonprescription

NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this

product � take more or for a longer time than directed

Drug Facts (continued)Heart attack and stroke warning: NSAIDs, except aspirin,increase the risk of heart attack, heart failure, and stroke.These can be fatal. The risk is higher if you use more thandirected or for longer than directed.Do not use� if you have ever had an allergic reaction to any other pain

reliever/fever reducer � unless you have time for a full night’s sleep � in children under 12 years of age� right before or after heart surgery � with any other product containing diphenhydramine, even one

used on skin � if you have sleeplessness without painAsk a doctor before use if� stomach bleeding warning applies to you � you have problems or serious side effects from taking pain

relievers or fever reducers � you have a history of stomach problems, such as heartburn � you have high blood pressure, heart disease, liver cirrhosis,

kidney disease, asthma, or had a stroke � you are taking a diuretic � you have a breathing problem such as emphysema or chronic

bronchitis � you have glaucoma � you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are� taking sedatives or tranquilizers, or any other sleep-aid� under a doctor’s care for any continuing medical illness � taking any other antihistamines � taking aspirin for heart attack or stroke, because ibuprofen may

decrease this benefit of aspirin � taking any other drugWhen using this product� drowsiness will occur � avoid alcoholic drinks� do not drive a motor vehicle or operate machinery� take with food or milk if stomach upset occurs

Drug Facts (continued)Stop use and ask a doctor if� you experience any of the following signs of stomach bleeding:

� feel faint � vomit blood � have bloody or black stools� have stomach pain that does not get better

� you have symptoms of heart problems or stroke:� chest pain � trouble breathing� weakness in one part or side of body� slurred speech � leg swelling

� pain gets worse or lasts more than 10 days� sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness. � redness or swelling is present in the painful area � any new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions � do not take more than directed� adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hours

Other information� each capsule contains: potassium 20 mg � read all warnings and directions before use. Keep carton. � store at 20-25°C (68-77°F) � avoid excessive heat above 40°C (104°F) � protect from light







UNPRINTED AREA FOR DATE & LOT CODING (UNVARNISHED)

128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS (CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) -

PRINTED SIDE OF CARTON

PRINTED AREA FOR DATE & LOT LASER CODING (VARNISHED)

0901

77e1

89bc

f09e

\Fin

al\F

inal

On:

29-

Sep

-201

6 02

:04

Reference ID

(b) (4)

(b) (4)


• HEADINGS


• LEADING

• BULLETS



TYPE SIZE

5.5 pt

5.5 pt

6 pt

4.5 pt

2 ems

.5 pt







Job Information

Identi�cation

Color Legend






100100Liquid Filled


Capsules


Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Uses � for relief of occasional sleeplessness when associated with minor aches and pains � helps you fall asleep and stay asleepWarnings� Ask your doctor before use if you are pregnant, under a doctor’s care for any continuing medical illness, age 60 or over, taking any other drug or have stomach problems. � This product may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. � Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer; unless you have time for a full night’s sleep; in children under 12 years or with any other product containing diphenhydramine.

� Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you � are age 60 or older � have had stomach ulcers or bleeding problems � take a blood thinning (anticoagulant) or steroid drug � take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this product � take more or for a longer time than directed.� Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.� When using this product drowsiness will occur. Do not drive a motor vehicle or operate machinery. Avoid alcoholic drinks. Directions � do not take more than directed � adults and children 12 years and over: take 2 capsules at bedtime � do not take more than 2 capsules in 24 hoursEach capsule contains: potassium 20 mgStore at 20-25°C (68-77°F) Avoid excessive heat above 40°C (104°F). Protect from light.Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVILFor most recent product information, visit www.Advil.comDistributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc. U.S. Patent 9,155,718

PAA077258



2"

6"

0901

77e1

8affc

238\

Fin

al\F

inal

On:

06-

Jan-

2017

21:

22


(b) (4)

(b) (4)

Date 22-FEB-2017 PASS # 1Component # PAA085999Drawing # DWG-00000431v02

Embossing - #2 sculpturedFull size file on Emboss layer

Embossing - #1Full size file on Emboss layer




Madison Artwork & Packaging CenterGraphic Ar ist:




Job Information

Identi�cation

Color Legend







• HEADINGS


• LEADING


• BULLETS




TYPE SIZE

9 pt

8 pt

8 pt

6 pt

6.5 pt

<39

5 pt

2 ems

1.5 pt, .5 pt

2 spaces

20 FREE ®





100Liquid Filled

Capsules

+20 Free80

FPO 128 Code085999

FPO 128 Code085999

FPO 128 Code085999

FPO 128 Code085999

3 0573 0167 56 7

PAA085999





Drug FactsActive ingredients (in each capsule) PurposesDiphenhydramine hydrochloride 25 mg................................... Nighttime sleep-aidSolubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*...................................Pain reliever(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Uses� for relief of occasional sleeplessness when associated with

minor aches and pains� helps you fall asleep and stay asleep

WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:� hives � facial swelling � asthma (wheezing)� shock � skin reddening � rash� blistersIf an allergic reaction occurs, stop use and seek medical helpright away.Stomach bleeding warning: This product contains an NSAID,which may cause severe stomach bleeding.The chance is higher if you � are age 60 or older� have had stomach ulcers or bleeding problems� take a blood thinning (anticoagulant) or steroid drug� take other drugs containing prescription or nonprescription

NSAIDs [aspirin, ibuprofen, naproxen, or others] � have 3 or more alcoholic drinks every day while using this

product � take more or for a longer time than directed

Drug Facts (continued)Heart attack and stroke warning: NSAIDs, except aspirin,increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more thandirected or for longer than directed.Do not use� if you have ever had an allergic reaction to any other pain

reliever/fever reducer � unless you have time for a full night’s sleep � in children under 12 years of age� right before or after heart surgery � with any other product containing diphenhydramine, even one

used on skin � if you have sleeplessness without painAsk a doctor before use if� stomach bleeding warning applies to you � you have problems or serious side effects from taking pain

relievers or fever reducers � you have a history of stomach problems, such as heartburn � you have high blood pressure, heart disease, liver cirrhosis,

kidney disease, asthma, or had a stroke � you are taking a diuretic � you have a breathing problem such as emphysema or chronic

bronchitis� you have glaucoma � you have trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are� taking sedatives or tranquilizers, or any other sleep-aid� under a doctor’s care for any continuing medical illness � taking any other antihistamines � taking aspirin for heart attack or stroke, because ibuprofen may

decrease this benefit of aspirin � taking any other drugWhen using this product� drowsiness will occur� avoid alcoholic drinks� do not drive a motor vehicle or operate machinery� take with food or milk if stomach upset occurs

Drug Facts (continued)Stop use and ask a doctor if� you experience any of the following signs of stomach bleeding:

� feel faint � vomit blood � have bloody or black stools� have stomach pain that does not get better

� you have symptoms of heart problems or stroke:� chest pain � trouble breathing� weakness in one part or side of body� slurred speech � leg swelling

� pain gets worse or lasts more than 10 days� sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness.� redness or swelling is present in the painful area� any new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. Itis especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because itmay cause problems in the unborn child or complications duringdelivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions � do not take more than directed� adults and children 12 years and over: take 2 capsules at bedtime� do not take more than 2 capsules in 24 hours

Other information� each capsule contains: potassium 20 mg � read all warnings and directions before use. Keep carton. � store at 20-25°C (68-77°F) � avoid excessive heat above 40°C (104°F) � protect from light




UNPRINTED AREA FOR DATE & LOTCODING (UNVARNISHED)

128 CODE AREA - SUBSET C 10 MIL DENSITY WITH 4 OR 6 DIGITS(CODE TO EXTEND TO EDGE OF FLAP - UNVARNISHED) -

PRINTED SIDE OF CARTON PRINTED AREA FOR DATE & LOTLASER CODING (VARNISHED)

Reference ID:

(b) (4)

(b) (4)

production - food and drug administration · drug facts text defined • headings •...

Documents