Equate Fiber Therapy Tablet
FDA Label NDC 49035-756

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product Equate Fiber Therapy (NDC 49035-756). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    Equate Fiber Therapy Caplets 100caplets (122100pvlr Ol)

    Equate Fiber Therapy Caplets 100caplets (122100pvlr Ol)

* Please review the disclaimer below.