Fiber Laxative Tablet
FDA Label NDC 54257-479

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magno-humphries, Inc. for the product Fiber Laxative (NDC 54257-479). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, 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)

Uses

  • relieves occasional constipation to help restore and maintain regularity
  • 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
  • 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 a doctor if rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Directions

  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may

    • cause choking. 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 of age and over: 2 caplets once a day up to 4 times a day
    • children under 12 years of age: ask a doctor

Other Information

  • each caplet contains: calcium 125 mg
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture

Inactive Ingredients

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose,
polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Questions?

call toll-free 1-800-935-6737

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