Konsyl Naturally Sweetened Psyllium Fiber (Psyllium Husk) Granule [Konsyl Pharmaceuticals, Inc.] -

KONSYL NATURALLY SWEETENED PSYLLIUM FIBER (PSYLLIUM HUSK) GRANULE [KONSYL PHARMACEUTICALS, INC.]
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NDC	0224-1822-03, 0224-1822-07, 0224-1822-80
Set ID	55996360-9721-46d6-8664-a5f423bba230
Category	HUMAN OTC DRUG LABEL
Packager	Konsyl Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number	PART334

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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

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

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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