KONSYL ORANGE DAILY FIBER- psyllium husk powder
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 Daily Fiber

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)

Label3

Package Labeling: (0224-1915-85)

Label4

KONSYL ORANGE DAILY FIBER
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0224-1915
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 12 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0224-1915-89	408 g in 1 BAG; Type 0: Not a Combination Product	12/01/2019	12/01/2019
2	NDC:0224-1915-85	30 in 1 CARTON	12/01/2019	11/01/2022
2		12 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/01/2019	11/01/2022

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Revised: 12/2021

Document Id: d455d16a-4579-4db3-e053-2a95a90a0eed

Set id: a0ad4bdd-0f2e-6630-e053-2a95a90a8ef6

Version: 2

Effective Time: 20211229

Konsyl Pharmaceuticals, Inc.