KONSYL ORANGE FLAVOR PSYLLIUM FIBER - SMOOTH TEXTURE- psyllium husk granule

Konsyl Orange Flavor Psyllium Fiber - Smooth Texture by

Drug Labeling and Warnings

Konsyl Orange Flavor Psyllium Fiber - Smooth Texture by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KONSYL Orange Flavor Psyllium Fiber - Smooth Texture

Active Ingredient (in each tablespoon)

Psyllium Hydrophilic Mucilloid 3.4 g

Purpose

Laxative

Uses

For relief of occasional constipation and to induce regularity. This product generally produces bowel movement 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 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 daily
• children under 6 years of age: consult a doctor.

Other Information

• each tablespoon contains Potassium 25mg, Sodium 5mg
  
• 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

Citric Acid, D&C Yellow No. 10, FD&C Yellow No. 6, Natural and Artificial Orange Flavor, Sugar

Questions or Comments?

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

Representative Labeling

Package Labeling: 0224-1852-80

Package Labeling: 0224-1852-81

INGREDIENTS AND APPEARANCE

KONSYL ORANGE FLAVOR PSYLLIUM FIBER - SMOOTH TEXTURE 
psyllium husk granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1852
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 12 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1852-06	538 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	04/01/2020
2	NDC: 0224-1852-80	538 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011
3	NDC: 0224-1852-81	30 in 1 BOX	03/31/2011
3		12 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0224-1852-13	30 in 1 BOX	03/31/2011	01/01/2020
4		12 g in 1 PACKET; Type 0: Not a Combination Product

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)