KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER - psyllium husk capsule 
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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Active ingredient (in each dose)               
Psyllium husk approx. 520 mg

Purpose

Bulk-forming laxative

Uses  - for relief of occasional constipation (irregularity)  - this product generally produces bowel movement in 12 to 72 hours

Warnings  Allergy Alert: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.  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.

Ask a doctor before use if you have - stomach pain, nausea, or vomiting  - a sudden change in bowel habits that persists over 2 weeks

Stop use and ask a doctor if - you fail to have a bowel movement or have rectal bleeding.  These could be sings of a serious condition.  - you need to use a laxative for more than 1 week  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions  - Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking.  See choking warning. - follow dosage below or use as directed by a doctor.  - drink a full glass (8 oz) of water or other liquid with each dose - continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years and over
5 capsules one to three times days
Children under 12 years
consult a doctor
LOT:  EXP: 

Other information  - keep tightly closed - store at room temperature - contains a 100% natural therapeutic fiber

Inactive ingredients  FDandC yellow #6, gelatin. polyethylene glycol. polysorbate 80

Supplements Facts  Serving Size: 6 capsules  Servings per Container:16  Amount Per Serving  %DV*  Calories 10  Total Carb. 3g.....1%  Dietary Fiber 3g.......11% Soluble Fiber 2g........+  Protein less than 1 gram.........+  Iron 0.4 mg.......2%  *Percent Daily Values (DV) are based on a 2.000 calorie diet.  not equal to + Daily Value (DV) not established  Uses An easy way to increase your daily fiber intake. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk may reduce the risk of heart disease by lowering cholesterol. One serving of this product provides 2.4 grams of this soluble fiber.  Consult a doctor if you intend to use this product as part of a cholesterol-lowering program  Directions Adults 12 yrs. and older: 2-6 capsuled for increasing daily fiber intake: 6 capsules for cholesterol lowering use.  Take product with 8 oz of liquid (swallow 1 capsule at a time) up to 3 times daily.  NOTICE:  Take this product with at least 8 oz (a full glass) of liquid. Taking without enough liquid may cause choking. Do not take if you have difficulty swallowing.  Questions or comments? 1-800-356-6795  8:30 a.m. to 5 p.m ET  Manufactured By: Konsyl Pharmaceuticals, Inc. Easton, MD 21601 www.konsyl.com  Konsyl Pharmaceuticals, Inc. 34076  0710 3 0224-1847-10 0

0224-1847-10  KONSYL  100% NATURAL PSYLLIUM FIBER SUPPLEMENT / LAXATIVE  Sugar Free Gluten Free Helps Lower Cholesterol  100 Capsules  Psyllium Hydrophilic Mucilloid SAFETY SEALED CAPSULES - DO NOT USE IF THE SEAL UNDER THE CAP IS BROKEN OR MISSING




Konsyl Natural Psyllium Fiber Outer

Konsyl2

KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1847
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK520 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
Product Characteristics
Colorwhite (CLEAR) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint Code P620
Contains    
Packaging
#Item CodePackage Description
1NDC:0224-1847-101 in 1 BOX
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33403/31/2011
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture

Revised: 03/2011
 
Konsyl Pharmaceuticals, Inc.