KONSYL ORANGE DAILY FIBER- psyllium husk powder

Konsyl Orange Daily Fiber by

Drug Labeling and Warnings

Konsyl Orange Daily Fiber 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 teaspoon)

Psyllium Hydrophilic Mucilloid 3.4g

Purpose

Bulk-forming laxative

Use

For relief of occasional constipation and aid in 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

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 12g dose 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 bag sealed for your protection
• do not use if seal of bag is broken or missing
• do not discard Konsyl into any plumbing system
• store below 86º F (30º C)
• keep bag tightly closed to protect from excessive moisture

Inactive Ingredients

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

Questions or Comments?

+1-410-822-5192 8:30 a.m. to 5 p.m. ET

Package Labeling: (

0224-1915-89)

Package Labeling: (

0224-1915-85)

INGREDIENTS AND APPEARANCE

KONSYL ORANGE DAILY FIBER 
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1915
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: 0224-1915-89	408 g in 1 BAG; Type 0: Not a Combination Product	12/01/2019
2	NDC: 0224-1915-85	30 in 1 CARTON	12/01/2019
2		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	12/01/2019

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)