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Name:Natural Vegetable Fiber Regular Flavor Smooth Texture Sugar Free
Manufacturer:Qualitest Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Natural Vegetable Fiber Regular Flavor Smooth Texture Sugar Free

NATURAL VEGETABLE FIBER  REGULAR FLAVOR SMOOTH TEXTURE SUGAR FREE - psyllium husk powder 
Qualitest Pharmaceuticals

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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Natural Vegetable Fiber Regular Flavor Smooth Texture Sugar Free

Active Ingredient (in each dose)                         
Psyllium husk 3.4 g

Purpose

Bulk-forming laxative

Uses  For relief of occasional constipation and restoring regularity. Natural bulk producing fiber encourages normal elimination without chemical stimulants.

Warnings  

Allergy alert: may cause 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

  •  abdominal pain, nausea, vomiting or rectal bleeding
  •  a sudden change in bowel habits that persists over a period of 2 weeks
  •  constipation associated with gastrointestinal disorders

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may effect how other drugs work.

Stop use and ask a doctor if constipation persists beyond 7 days. This could be a sign 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  This product generally produces effect in 12-72 hours. Put one dose into an empty glass. Fill glass with at least 8 oz of water or your favorite beverage. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. 

  • mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other liquid.
  • taking this product without enough liquid may cause choking, see choking warning
  • can be taken before or after meals
Age
Dose
adults and children 12 years and older
1 rounded teaspoon (5.4 g) in 8 oz of liquid. up to 3 times daily.
children 6 to under 12 years
1/2 adult dose in 8 oz. liquid. up to 3 times daily
children under 6 years
consult a doctor

Other information 

  • each 5.4g dose contains: potassium 27 mg, sodium 6 mg, calcium 7 mg.

  •  store below 30 Degree C (86"F). tightly closed to protect from humidity

Inactive Ingredients maltodextrin, silicon dioxide.

*This product is not manufactured or distributed by Procter and Gamble, owner or the registered trademark METAMUCIL.

Manufactured in the USA  for Qualitest Pharmaceuticals 

130 Vintage Drive  Huntsville, AL 35811

NDC 0603-0992-63

SUGAR FREE

Not  a low calorie product

*Compare to the Active Ingredient in METAMUCIL

REGULAR FLAVOR

Natural Vegatable Fiber 

100% NATURAL PSYLLIUM FIBER 

Daily Source of Soluble Fiber 

Dietary Fiber Supplement/Bulk Forming Laxative 

Fiber Therapy for Regularity

SMOOTH TEXTURE 

48 Teaspoon Doses 

NET WT 10 OZ (283 g)

Fill Controlled by weight not volume 

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

NaturalVegetableFiber


NATURAL VEGETABLE FIBER   REGULAR FLAVOR SMOOTH TEXTURE SUGAR FREE
psyllium husk powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0992
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK 3.4 g  in 5.4 g
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN  
SILICON DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-0992-63 283 g in 1 CANISTER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part334 06/02/2011

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Konsyl Pharmaceuticals, Inc. 102463866 manufacture

Revised: 06/2011 Qualitest Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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