KONSYL ORIGINAL 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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Active ingredient (in each dose)                

Psyllium Hydrophilic Mucilloid 6 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 psyllium powder may cause an allergic reaction in people sensitive to psyllium.

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 dose (one rounded teaspoonful) into a shaker cup or closed container; with at least 8 oz. of juice, water or other beverage; shake 3 to 5 seconds; drink 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/ adult dose, in 8 oz. of fluid; 1-3 times daily.  Children under 6 years: ask a doctor.

Other information  - each 6.0 gram dose contains: Calcium 10mg, Potassium 55 mg, Sodium 5 mg.  - maximum daily dose (3 teaspoonfuls) is very low in sodium  - do not discard KONSYL  powder into any plumbing systems  - Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines.  - no additives, No sugars, gluten free, No flavors, 100% Natural  - safe for diabetics, non habit-forming  - 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 excessive moisture  - can be taken 1 to 3 times daily, before or after meals, mornings or evenings

Inactive Ingredients  None

Questions or comments?  1-800-356-6795  8:30 a.m to 5 p.m. ET.

Dietary Fiber Supplements  Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psylluim husk may reduce the risk of Coronary Heart Disease (CHD) by lowering cholesterol. ONE ADULT DOSE OF KONSYL CONTAINS 3.0 GRAMS OF THIS SOLUBLE FIBER = 6 GRAMS OF PSYLLIUM.  Dosage Adults 12 years and older:  1 Rounded teaspoonful in 8 oz. of fluid 2 TIMES DAILY, follow with additional fluid to aid product action, before or after meals, mornings or evenings. Children under 12 years: Consult a doctor.  Notice Ask a doctor before use if you consider taking this product as part of a cholesterol-lowering program.  See directions for use before taking this product.  Supplement Facts  Serving size (dose): 1 rounded teaspoonful psyllium  6.0g   Servings per container  75  Amount Per Serving  %DV*  Calories (Available)  3  Sodium  0%  Carbohydrates (Available)  .05g  0%  Dietary Fiber  5g  20%  Soluble Fiber 3g  -  Sugars  0 -  Calcium 0% Iron  10 %  * percent Daily Values (DV) are based on a 2,000 calorie diet.  - Daily Value (DV) not established. Active Ingredient Each rounded teaspoonful contains 6 grams or 100 % Natural Psullium Hydrophilic Mucilloid.  equal to 3 grams of Soluble Fiber.  Inactive Ingredients  None  N3  0224-1801-07 2 * Starting out with Konsyl?  When using this product, physicians recommend a gradual increase in dietary fiber.  If minor gas or bloating occurs, begin with a half-dose of KONSYL and slowly increase the dose over several days.  Always follow with 8 oz. of fluid.  Manufactured By Konsyl Pharmaceuticals, Inc.  Easton, MD 21601www.konsyl.com  Konsyl Pharmaceuticals, Inc.  33787  0710

KONSYL  ORIGINAL FORMULA PSYLLIUM FIBER Psyllium Hydrophilic Mucilloid Gluten Free Helps Lower Cholesterol  Sugar Free Net Weight 6.0 g  SUPPLEMENT / LAXATIVE  TAMPER-EVIDENT PACKAGE. DO NOT USE IF OPENED OR DAMAGED.  DIRECTIONS FOR USE:  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 LIQUID MAY CAUSE CHOKING. SEE WARNINGS.  1. Sprinkle one packet into a shaker or glass containing. 8 oz. of juice, water or your favorite beverages.  2. Cover. Shake well for 3-5 seconds, or stir well. 3. Drink promptly. If mixture thickens, add more liquid and stir.  Follow with additional liquid to aid product action.  DOSAGE: Adults and children 12 years of age and over: One packet (or dose) 1 to 3 times daily, before or after meals, or as directed by a doctor.  Children 6 to under 12 years of age: 1/2 adult dose, or as directed by a doctor.  Children under 6 years of age: Consult a doctor.  INDICATIONS: For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.  See insert or carton for complete WARNINGS.  ALLERGY ALERT: Inhaled or ingested psyllium power may cause an allergic reaction in people sensitive to psyllium. Manufactured by konsyl Pharmaceutical, Inc. Easton, MD 21601 Store below 86 Degree F (30 Degree Centigrade)

NDC 0224-1801-07  KONSYL  ORIGINAL FORMULA PSYLLIUM FIBER Psyllium Hydrophilic Mucilloid Heart Healthy 100% Natural  Gluten Free  Helps Lower Cholesterol Sugar Free  SUPPLEMENT / LAXATIVE  NET WEIGHT 450g (15.9oz)  (FILL CONTROLLED BY WEIGHT NOT VOLUME)

NDC 0224-1801-06  KONSYL  ORIGINAL FORMULA PSYLLIUM FIBER Psyllium Hydrophilic Mucilloid Heart Healthy 100% Natural Gluten Free Helps Lower Cholesterol  Sugar Free  K PAREVE  SUPPLEMENT / LAXATIVE  NET WEIGHT 300g (10.6 oz) (FILL CONTROLLED BY WEIGHT NOT VOLUME)

NDC 0224-1801-35  KONSYL  ORIGINAL FORMULA PSYLLIUM FIBER Psyllium Hydrophilic Mucilloid Heart Healthy 100% Natural Gluten Free Helps Lower Cholesterol  Sugar Free  K PAREVE  SUPPLEMENT / LAXATIVE  30-Net Weight 6g Packets

Konsyl Original Formula Psyllium Fiber Sachet

Konsyl Original Formula Psyllium Fiber Outer 1

KONSYL ORIGINAL FORMULA PSYLLIUM FIBER 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK6 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:0224-1801-3530 in 1 BOX
16 g in 1 PACKET
2NDC:0224-1801-07450 g in 1 CANISTER
3NDC:0224-1801-06300 g in 1 CANISTER
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.