vicks ® dayquil ® and vicks ® nyquil ® severe cold and flu
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VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen,phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenes in The Procter & Gamble Manufacturing CompanyDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Vicks DayQuil and Vicks NyQuil
Severe Cold and FluDayQuil SEVERE COLD & FLUDrug Facts
Active ingredients (in each caplet) PurposeAcetaminophen 325 mg Pain reliever/fever reducerDextromethorphan HBr 10 mg Cough suppressantGuaifenesin 200 mg ExpectorantPhenylephrine HCl 5 mg Nasal decongestant
Usestemporarily relieves common cold/flu symptoms:
nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways ofbothersome mucus and make coughs more productive.
Warnings
Liver warningThis product contains acetaminophen.
Severe liver damage may occur if you takemore than 4 doses in 24 hrs, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product
Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,rash, nausea, or vomiting, consult a doctor promptly.
® ® ® ®
Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctor or pharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks afterstopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.
Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacis t before use if you are taking the blood thinning drug warfarin.
When us ing this product, do not use more than directed.
Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breas t-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warningTaking more than directed can cause serious health problems. In case of overdose, get medical help orcontact a Poison Control Center right away. Quick medical attention is critical for adults as well as forchildren even if you do not notice any signs or symptoms.
Directionstake only as directed - see Overdose warningdo not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use
when us ing other DayQuil or NyQuil products , carefully read each label to ensure correctdos ing
®
Other informationeach caplet contains : sodium 4 mgstore at room temperature
Inactive ingredientscroscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, mica, microcrystallinecellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch,silicon dioxide, stearic acid, talc, titanium dioxide
Questions?1-800-251-3374NyQuil SEVERE COLD & FLUDrug Facts
Active ingredients (in each caplet) PurposeAcetaminophen 325 mg Pain reliever/fever reducerDextromethorphan HBr 10 mg Cough suppressantDoxylamine succinate 6.25 mg AntihistaminePhenylephrine HCl 5 mg Nasal decongestant
Usestemporarily relieves common cold/flu symptoms:
nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationcough to help you sleepminor aches & painsheadachefeversore throatrunny nose & sneezingreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage
Warnings
Liver warningThis product contains acetaminophen.
Severe liver damage may occur if you takemore than 4 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product
Sore throat warningIf sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.
Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctor or pharmacist.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks afterstopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.to make a child sleep
Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronicbronchitis, or emphysematrouble urinating due to enlarged prostate gland
Ask a doctor or pharmacis t before use if you aretaking sedatives or tranquilizerstaking the blood thinning drug warfarin
When us ing this productdo not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breas t-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warningTaking more than directed can cause serious health problems. In case of overdose, get medical help orcontact a Poison Control Center right away. Quick medical attention is critical for adults as well as forchildren even if you do not notice any signs or symptoms.
Directionstake only as directed - see Overdose warningdo not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use
when us ing other DayQuil or NyQuil products , carefully read each label to ensure correctdos ing
Other informationstore at room temperature
Inactive ingredientscrospovidone, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, magnesium stearate,mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone,pregelatinized starch, stearic acid, talc, titanium dioxide
Questions?1-800-362-1683DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
PRINCIPAL DISPLAY PANEL - 24 Caplet Kit CartonMAX STRENGTH VICKS DayQuil SEVERE
COLD & FLUAcetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureCoughChest Congestion
Non-Drowsy16 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE
COLD & FLU
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Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureSneezing, Runny NoseCough
Nighttime Relief8 NYQUIL SEVERE CAPLETS; TOTAL 24 CAPLETS
PRINCIPAL DISPLAY PANEL - 48 Caplet Kit CartonMAX STRENGTH VICKS DayQuil SEVERE
COLD & FLUAcetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureCoughChest Congestion
Non-Drowsy32 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE
COLD & FLUAcetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureSneezing, Runny NoseCough
Nighttime Relief16 NYQUIL SEVERE CAPLETS; TOTAL 48 CAPLETS
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®
®
PRINCIPAL DISPLAY PANEL - 72 Caplet Kit CartonMAX STRENGTH VICKS DayQuil SEVERE
COLD & FLUAcetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureCoughChest Congestion
Non-Drowsy
®
®
48 DAYQUIL SEVERE CAPLETS;NyQuil SEVERE
COLD & FLUAcetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat, Minor Aches & PainsNasal/Sinus Congestion & Sinus PressureSneezing, Runny NoseCough
Nighttime Relief24 NYQUIL SEVERE CAPLETS; TOTAL 72 CAPLETS
®
VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenesin kit
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:370 0 0 -416
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -416 -48 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14
Quantity of PartsPart # Package Quantity Total Product Quantity
Pa rt 1 16 BLISTER PACK 32
Pa rt 2 8 BLISTER PACK 16
Part 1 of 2
VICKS DAYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, guiafenesin and dextromethorphan hydrobromide tablet
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ) GUAIFENESIN 20 0 mg
Inactive IngredientsIngredient Name Strength
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor o range Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code DQ
Contains
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 16 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Part 2 of 2
VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, doxylamine succinate, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet,coated
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL) DOXYLAMINE SUCCINATE 6 .25 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
Inactive IngredientsIngredient Name Strength
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor green Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code NQ
Contains
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 8 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenesin kit
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:370 0 0 -417
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -417-72 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14
Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 24 BLISTER PACK 48
Pa rt 2 12 BLISTER PACK 24
Part 1 of 2
VICKS DAYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, guiafenesin and dextromethorphan hydrobromide tablet
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ) GUAIFENESIN 20 0 mg
Inactive IngredientsIngredient Name Strength
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor o range Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code DQ
Contains
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 24 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Part 2 of 2
VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, doxylamine succinate, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet,coated
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL) DOXYLAMINE SUCCINATE 6 .25 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
Inactive IngredientsIngredient Name Strength
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor green Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code NQ
Contains
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 12 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate andguaifenesin kit
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:370 0 0 -415
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:370 0 0 -415-24 1 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 7/21/20 14
Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 8 BLISTER PACK 16
Pa rt 2 4 BLISTER PACK 8
Part 1 of 2
VICKS DAYQUIL SEVERE COLD AND FLU acetaminophen, phenylephrine hydrochloride, guiafenesin and dextromethorphan hydrobromide tablet
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ) GUAIFENESIN 20 0 mg
Inactive IngredientsIngredient Name Strength
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor o range Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code DQ
Contains
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 8 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Part 2 of 2
VICKS NYQUIL SEVERE COLD AND FLU acetaminophen, doxylamine succinate, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet,coated
Product InformationRoute of Adminis tration ORAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)(DEXTROMETHORPHAN - UNII:7355X3ROTS)
DEXTROMETHORPHANHYDROBROMIDE 10 mg
DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL) DOXYLAMINE SUCCINATE 6 .25 mg
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -UNII:1WS29 7W6 MV)
PHENYLEPHRINEHYDROCHLORIDE 5 mg
Inactive IngredientsIngredient Name Strength
CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
MICA (UNII: V8 A1AW0 8 8 0 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
Product CharacteristicsColor green Score no sco re
Shape OVAL Siz e 19 mm
Flavor Imprint Code NQ
Contains
Packaging
The Procter & Gamble Manufacturing Company
# Item Code Package Description Marketing Start Date Marketing End Date1 4 in 1 CARTON
1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph fina l part341 0 7/21/20 14
Labeler - T he Procter & Gamble Manufacturing Company (004238200)
Revised: 1/2020
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