KONSYL SUGAR FREE ORANGE WITH STEVIA- psyllium husk powder

Konsyl Sugar free Orange With Stevia by

Drug Labeling and Warnings

Konsyl Sugar free Orange With Stevia 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 3.5g

Purpose

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

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 of 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 5.8g dose contains Potassium 35mg
• 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 use discard konsyl inot any plumbing system
• store below 86° F (30° C)
• keep container tightly closed-protect from excessive moisture
• can be taken before or after meals, mornings or eveings

Inactive Ingredients

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

Questions or Comments?

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

Konsyl Sugar free Orange With Stevia, 450g (

0224-1884-81)

Package Labeling: 0224-1884-82

INGREDIENTS AND APPEARANCE

KONSYL SUGAR FREE ORANGE WITH STEVIA 
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1884
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.5 g  in 5.8 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
REBAUDIOSIDE A (UNII: B3FUD0528F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1884-81	77 in 1 CARTON	10/01/2018
1		5.8 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 0224-1884-82	30 in 1 CARTON	10/01/2018
2		5.8 g in 1 PACKAGE; 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	10/01/2018

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)