KONSYL SUGAR FREE ORANGE WITH STEVIA- psyllium husk powder Konsyl Pharmaceuticals , Inc.Disclaimer: 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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Konsyl Sugar free Orange With Stevia

Drug Facts

Active Ingredient (in each teaspoon)

Psyllium Hydrophilic Mucilloid 3.5g

Purpose

Laxative

Use

For relief of occasional constipation and aid in regularity. This product generally produces bowelmovements within 12-72 hours.

Warnings

Choking �Taking this product without adequate fluid may cause it to swell and block your throat oresophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If youexperience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seekimmediate medical attention.

Do not usewhen abdominal pain, nausea or vomiting are present unless directed by a doctorif constipation lasts more than seven daysif you have difficulty swallowing

Ask a doctor before use if you havenoticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor ifyou experience rectal bleeding or fail to have a bowel movement, as these may be signs of a seriouscondition

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Mix this product with at least 8 ounces (a full glass) of water of other fluid. Taking this product withoutenough fluid may cause choking. See choking warning.

adults and children 12 years and older one teaspoon 1 to 3 times daily

children 6 to under 12 years of age 1/2 teaspoon 1 to 3 times dailychildren under 6 years of age consult a doctor

Other Informationeach 5.8g dose contains Potass ium 35mglaxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before orafter taking other medicinestamper-evident bottle mouth sealed for your protectiondo not use if imprinted inner seal is broken or missing do not use discard konsyl inot any plumbing systemstore below 86° F (30° C)keep container tightly closed-protect from excessive moisturecan be taken before or after meals, mornings or eveings

Inactive Ingredients

Citric Acid, FD&C Yellow No.6, Maltodextrin, Natural and Artificial Orange Flavor, Rebaudioside A,Silicon Dioxide.

Questions or Comments?

1-800-356-6795 8:30 a.m. to 5 p.m.ET.

Konsyl Sugar free Orange With Stevia, 450g (0224-1884-81)

Package Labeling: 0224-1884-82

KONSYL SUGAR FREE ORANGE WITH STEVIA psyllium husk powder

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 224-18 8 4

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

PSYLLIUM HUSK (UNII: 0 SHO5340 7G) (PSYLLIUM HUSK - UNII:0 SHO5340 7G) PSYLLIUM HUSK 3.5 g in 5.8 g

Inactive IngredientsIngredient Name Strength

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

REBAUDIO SIDE A (UNII: B3FUD0 528 F)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:0 224-18 8 4-8 1 77 in 1 CARTON 10 /0 1/20 18

1 5.8 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

2 NDC:0 224-18 8 4-8 2 30 in 1 CARTON 10 /0 1/20 18

2 5.8 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

Konsyl Pharmaceuticals, Inc.

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part334 10 /0 1/20 18

Labeler - Konsyl Pharmaceuticals , Inc. (102463866)

Revised: 10/2019