Fiber Laxative

CALCIUM POLYCARBOPHIL ORAL HUMAN OTC DRUG

Fiber Laxative is an FDA drug label for the active ingredient CALCIUM POLYCARBOPHIL manufactured by Magno-Humphries, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231027.

Generic name
CALCIUM POLYCARBOPHIL
Manufacturer
Magno-Humphries, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
54257-379
Application
M007
Label effective
20231027

Active ingredients

Active ingredient (in each tablet) Calcium polycarbophil 625 mg (Equivalent to 500 mg polycarbophil) Purpose Bulk-forming laxative

Indications & Usage

Uses relieves occasional constipation to help restore and maintain regularity this product generally produces bowel movement in 12 to 72 hours

Dosage & Administration

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 2 tablets once a day up to 4 times a day adults and children 12 years of age and over: ask a doctor children under 12 years of age:

Contraindications

Not available.

Warnings

Warnings 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. Choking: 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 tablets in a 24 hour period unless directed b y a doctor Stop use and ask a 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Adverse Reactions

Not available.