FDA Label for Equate Fiber Therapy

View Indications, Usage & Precautions

Equate Fiber Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores,inc.,. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Caplet)



Methylcellulose 500mg


Purpose



Bulk-forming laxative


Uses



  • •helps restore and maintain regularity and relieves constipation (irregularity)
  • •in the treatment of constipation associated with other bowel disorders when recommended by a doctor

Warnings



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 or vomiting
  • •sensitivity to any of the ingredients
  • •a sudden change in bowel habits that persists over a period of 2 weeks

When Using This Product



  • •do not exceed recommended maximum daily dose unless directed by a doctor
  • •do not use laxative products for a period longer than one week unless directed by a doctor

Stop Use And Ask A Doctor If



  • •rectal bleeding occurs
  • •you fail to have a bowel movement after use

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

  • •take 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 choking warning.
  • AGE

    DOSE

    MAXIMUM DOSE

    adults & children over 12 years

    2 caplets

    up to 6 times daily

    children( 6 - 12 years )

    1 caplet.

    up to 6 times daily

    children under 6 years

    ask a doctor

    ask a doctor


Other Information



  • each caplet contains: appx. 18 mg of calcium
  • •store at room temperature 15°-30° C( 59°-86° F)
  • •protect contents from moisture
  • •keep tightly closed

Inactive Ingredients



adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica.

Do not use if printed seal under cap is torn or missing.


Principal Display Panel



NDC 49035-756-10 Compare to Citrucel® Caplets Active Ingredients*

equate®

Fiber Therapy

Methylcellulose

  • •100% Soluble Fiber for Controlled Regularity
  • •Easy to take Caplets

    500 mg 100 CAPLETS

  • GLUTEN FREE

    Satisfaction guaranteed-for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    Distributed by:

    Wal-Mart Stores, Inc., Bentonville, AR 72716

    ©Wal-Mart Stores, Inc.

    *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Citrucel® Caplets


* Please review the disclaimer below.