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  5. Label Information: Fiber Laxative

FDA Label for Fiber Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fiber Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Magno-humphries, 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)



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


Package Label.Principal Display Panel




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