Fiber Therapy Tablet
FDA Label NDC 49035-147

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 Fiber Therapy (NDC 49035-147). 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, use(s), warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask doctor if, 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)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Use(S)

  • relieves occasional constipation
  • this product generally produces bowel movement in 12 to 72 hours

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
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks

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 affect how other drugs work.

When Using This Product

  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 caplets in a 24 hour period unless directed by a  doctor

Stop Use And Ask Doctor If

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding.

    • These could be signs of a serious condition.

Keep Out Of Reach Of Children

In case of over dose, get medical help or contact a Poison Control Center right away

Directions

  • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning.
  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit

    • adults and children 12 years and over2 caplets, 1 to 4 times a day 
     children under 12 years  ask a doctor







Other Information

  • each caplet contains: calcium 135 mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • protect contents from moisture

Inactive Ingredients

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.

Principal Display Panel

NDC 49035-147-94
equate
compare to Fibercon Active Ingredient
Fiber
Therapy
Calcium Polycarbophil
Bulk-Forming Laxative for Regularity


  • Gentle enough for everyday use
  • Just as effective as fiber powders

    • 625 mg
    140 CAPLETS


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