KONSYL ORIGINAL FORMULA PSYLLIUM FIBER- psyllium husk granule

KONSYL Original Formula Psyllium Fiber by

Drug Labeling and Warnings

KONSYL Original Formula 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 Original Formula Psyllium Fiber

Active Ingredients (in each teaspoon)

Psyllium Hydrophilic Mucilloid 6g

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 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 6g dose contains: Potassium 50mg
• laxatives, including bulk fibers, may affect how other 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

none

Questions or comments?

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

Package Labeling

Package Labeling: 0224-1801-80

Package Labeling: 0224-1801-84

Package Labeling: 0224-1801-88

INGREDIENTS AND APPEARANCE

KONSYL ORIGINAL FORMULA PSYLLIUM FIBER 
psyllium husk granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	6 g  in 6 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1801-84	30 in 1 BOX	03/31/2011
1		6 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0224-1801-35	30 in 1 BOX	03/31/2011	03/01/2020
2		6 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0224-1801-07	450 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	04/01/2020
4	NDC: 0224-1801-81	450 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011
5	NDC: 0224-1801-06	300 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	04/01/2020
6	NDC: 0224-1801-80	300 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011
7	NDC: 0224-1801-88	402 g in 1 BOTTLE; Type 0: Not a Combination Product	10/17/2018

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)