KONSYL NATURALLY SWEETENED PSYLLIUM FIBER- psyllium husk granule

Konsyl Naturally Sweetened Psyllium Fiber by

Drug Labeling and Warnings

Konsyl Naturally Sweetened Psyllium Fiber by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Konsyl Naturally Sweetened Psyllium Fiber

Active ingredient (in each teaspoon)

Psyllium Hydrophilic Mucilloid 3.4 g

Purpose

Laxative

Uses

• For relief of occasional constipation and to induce regularity.
• This product generally produces bowel movements within 12-72 hours.

Warnings

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

Do not use

• when abdominal pain, nausea or vomiting are present unless directed by a doctor
• if constipation lasts more than seven days
• if you have difficulty swallowing

Ask a doctor before use if you have

• noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

• you experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition

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 or other fluid.  Taking this product without enough liquid may cause choking.  See choking warning.

• adults and children 12 years and over: one teaspoon 1 to 3 times daily
• children 6 years to under 12 years of age: 1/2 teaspoon 1 to 3 times daily
• children under 6 years of age: consult a doctor

Other Information

• each 6.5 g dose contains: Potassium 30mg
• laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines
• tamper-evident bottle mouth sealed for your protection
• do not use if imprinted inner seal is broken or missing
• do not discard Konsyl into any plumbing system
• store below 86  degrees F (30 degrees C)
• keep container tightly closed-protect from excessive moisture
• can be taken before or after meals, mornings or evenings

Inactive Ingredients

Dextrose

Questions or Commentts?

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

Representative Labeling

Package Labeling: 0224-1822-80

INGREDIENTS AND APPEARANCE

KONSYL NATURALLY SWEETENED PSYLLIUM FIBER 
psyllium husk granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1822
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g  in 6.5 g

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1822-03	397 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	02/01/2020
2	NDC: 0224-1822-07	500 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	02/01/2012
3	NDC: 0224-1822-80	397 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/31/2011

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Registrant - Konsyl Pharmaceuticals, Inc. (102463866)