KONSYL ORANGE EXTRA STRENGTH FORMULA- 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 Extra Strength Formula

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:

Label

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/17/2015	10/01/2020

Labeler - Konsyl Pharmaceuticals, Inc (102463866)

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

Revised: 12/2018

Document Id: 7c5c6686-687e-5c30-e053-2a91aa0a0f69

Set id: 281d9ad4-8ea0-4d32-aa92-bc826587b611

Version: 4

Effective Time: 20181206

Konsyl Pharmaceuticals, Inc