equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor

Dosage form: granule, for solution
Ingredients: PSYLLIUM HUSK 3.5g in 5.8g
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-066

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.

equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor

equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor


Active Ingredient
  • Psyllium husk 3.5g

Purpose

Bulk-forming laxative

Uses
  •  for relief of occasional constipation and restoring regularity
  • generally produces bowel movement in 12-72 hours

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 persist over a period of 2 weeks
  • constipation associated with gastrointestinal disorders

Ask a 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
  • you experience rectal bleeding
  • you fail to have a bowel movement after use of a laxative These could 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. (1-800-222-1222)

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

AgeDose
adults and children 12 years and older
1 level teaspoonful (5.8g) sprinkled in 8 oz of liquid, up to 3 times daily
children 6 to under 12 years
1/2 adult dose in 8 oz. of liquid, up to 3 times daily
children under 6 years
consult a doctor

Other information
  • each dose contains: calcium 6 mg; potassium 30 mg; sodium 5 mg
  • PHENYLKETONURICS:Contains phenylantanine, 21mg per teaspoonful
  • store below 30oC (86oF), tightly closed to protect from humidity

Inactive Ingredients

apsartame, citric acid, FD and C Yellow #6, (Sunset Yelow), flavoring, maltodextrin, silicon dioxide

Distributed by:
  • Wal-Mark Stores, Inc, Bentonville, AR 72716 Wal-Mart Stores, Inc, This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Metamucil MultiHealth 34729 0312

Representative Label

Representative California Proposition 65 Label

EQUATE SUGAR FREE FIBER THERAPY SMOOTH TEXTURE ORANGE FLAVOR 
psyllium husk granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-066
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.5 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
SILICON DIOXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (ORANGE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-066-23661 g in 1 BOTTLE
2NDC:49035-066-481043 g in 1 BOTTLE
3NDC:49035-066-39283 g in 1 BOTTLE
4NDC:49035-066-81661 g in 1 BOTTLE
5NDC:49035-066-831043 g in 1 BOTTLE
6NDC:49035-066-82283 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/05/2012
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
Konsyl Pharmaceuticals, Inc102463866manufacture(49035-066)

Revised: 08/2013
 
Wal-Mart Stores Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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