Active Ingredient (In Each Tablet)
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
Fiber Tabs Tablet, Film Coated
FDA Label NDC 0904-2500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Fiber Tabs (NDC 0904-2500). 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 tablet), purpose, uses, choking:, 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 a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Bulk-forming fiber laxative
Uses
- relieves occasional constipation to help restore and maintain regularity
- this product generally produces bowel movement in 12 to 72 hours
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take each dose of this product 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.
- Do not take more than 4 doses in 24 hours
| age | recommended dose | daily maximum |
|---|---|---|
| adults and children 12 years of age and over | 2 tablets | 1 to 4 times a day |
| children under 12 years | consult a physician |
Other Information
- each tablet contains: 140 mg calcium
- protect contents from moisture
- store at room temperature, USP
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid
Questions Or Comments?
To report side effects call: 1-800-616-2471
Principal Display Panel
Fiber-Tabs
Calcium Polycarbophil Bulk-Forming Fiber Laxative
90 Tablets
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA
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