KONSYL ORANGE FLAVOR PSYLLIUM FIBER - ORIGINAL TEXTURE- psyllium husk granule
Konsyl Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KONSYL Orange Flavor Psyllium Fiber - Original 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 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

Citric acid, FD and C Yellow No. 6, natural and artificial flavor, sugar

Questions or Comments?

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

Representative Labeling

KONSYL ORANGE FLAVOR PSYLLIUM FIBER - ORIGINAL TEXTURE
psyllium husk granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0224-1841
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 11 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0224-1841-03	397 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	04/01/2020
2	NDC:0224-1841-80	397 g in 1 CANISTER; Type 0: Not a Combination Product	03/31/2011	12/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/31/2011	04/01/2020

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Name	Address	ID/FEI	Business Operations
Establishment
Konsyl Pharmaceuticals, Inc.		102463866	manufacture(0224-1841)

Revised: 12/2018

Document Id: 7c451e81-a661-870d-e053-2991aa0aed02

Set id: 379c96c4-027b-4e07-9f1a-803bde6d7078

Version: 6

Effective Time: 20181205

Konsyl Pharmaceuticals, Inc.