KONSYL EASY MIX FORMULA PSYLLIUM FIBER- psyllium husk granule 
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 Easy Mix Formula Psyllium Fiber

Active ingredient (in each dose)

Psyllium Hydrophilic Mucilloid 4.3 grams . . . . . . . . . .

Purpose

Bulk-Forming Laxative

Use For relief of occasional constipation and to induce regularity. This product generally produces bowel movements within 12 to 72 hours.

Warnings Allergy alert  As with any natural grain product, Inhaled or ingested psyillum powder may cause an allergic reaction in people sensitive to psyIllum.

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  laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have  - a sudden change in bowel habits that persists over a period of two weeks

Stop use and ask a doctor if  - you experience rectal bleeding  - you fail to have a bowel movement

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 (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warnings.

Adults and children 12 years and older: sprinkle one teaspoonful into a glass with 8 oz. of juice, water or other fluid; stir briskly 3-5 seconds; drinks promptly; if mixture thickens, add more fluid, stir; follow with additional fluid to aid product action; take 1-3 times daily.

Children 6 years to under 12 years: 1/2 adult dose, in 8 oz. of fluid; 1-3 times daily.

Children under 6 years: ask a doctor.

Other information  - each 6g dose contains: Calcium 8 mg, Potassium 37 mg, Sodium 7 mg.  - 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  - store below 86 degree F (30 degree Centigrade)  - keep container tightly closed - protect from moisture  Heart Healthy - Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk may reduce the risk of Corinary Heart Disease (CHD) by lowering cholesterol. One adult dose of this product contains 2 grams of this soluble fiber.

Inactive Ingredients Maltodextrin, silicon dioxide

Questions? Call  Konsyl Pharmaceuticals, Inc. at 1-800-356-6795  8:30 a.m. to 5 p.m. ET.

Manufactured by  Konsyl Pharmaceutiucals, Inc.  Easton, MD 21601 c Konsyl Pharmaceutiucals, Inc.  www.konsyl.com  34701  0710    N3  0224-1856-06   5

NDC 0224-1856-06  K O N S Y L  EASY MIX FORMULA  PSYLLIUM FIBER  Psyllium Hydrophilic Mucilloid  Heart Healthy  Sugar Free  Gluten Free  Helps Lower Cholesterol  K PAREVE  SUPPLEMENT / LAXATIVE  NET WEIGHT 300 g (10.6 oz)  (FILL CONTROLLED BY WEIGHT NOT VOLUME)

KONSYL Easy Mix Formula Psyllium Fiber Outer

KONSYL EASY MIX FORMULA PSYLLIUM FIBER 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0224-1856
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK4.3 g  in 6 g
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
SILICON DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1856-06300 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/31/2011
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-1856)

Revised: 8/2013
 
Konsyl Pharmaceuticals, Inc.