KONSYL ORANGE EXTRA STRENGTH FORMULA- psyllium husk powder

Konsyl Orange Extra Strength Formula by

Drug Labeling and Warnings

Konsyl Orange Extra Strength Formula by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablespoon)

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 causechoking. 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 tablespoon 1 to 3 times daily
• children 6 to under 12 years of age: 1/2 tablespoon 1 to 3 times daily
• children under 6 years of age: consult a doctor

Other Information

• each 9.0g close contains ​Potassium​ 50mg
• laxatives, including bulk fibers, may effect how other medicines work, wait 1-2 hours before or after taking other medicine
• 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 0​ f (30 ​0 ​C)
• keep container tightly closed-protect from excessive moisture
• can be taken before or after meals, mornings or evenings

Inactive Ingredients

Citric Acid, FD&C Yellow No. 6, Maltodextrin, Natural and Artificial Orange Flavor, Silicon Dioxide, Stevia

Questions or Comments?

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

​Package Labeling:

INGREDIENTS AND APPEARANCE

KONSYL ORANGE EXTRA STRENGTH FORMULA 
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1879
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1879-81	297 g in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2015	10/01/2020
2	NDC: 0224-1879-80	405 g in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2015	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/17/2015	10/01/2020

Labeler - Konsyl Pharmaceuticals, Inc (102463866)

Establishment
Name	Address	ID/FEI	Business Operations
Konsyl Pharmaceuticals, Inc		102463866	manufacture(0224-1879)