Drug Facts
Active ingredient (in each caplet)
Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
Fiber Tabs Tablet, Film Coated
FDA Label NDC 0904-2500
16 label sections · Submitted to the FDA by Major Pharmaceuticals · 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 drug facts, otc - purpose, uses, 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 a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Bulk-forming laxative
Uses
- relieves occasional constipation (irregularity)
- 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 Fiber-Tabs two 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
you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- take each dose of this product with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
| adults and children 12 years of age and over | 2 caplets, 1 to 4 times per day |
| children under 12 years of age | ask a doctor |
Other Information
- each caplet contains: calcium 125 mg
- do not use if printed seal under cap is torn or missing
- store in a dry place at 15° – 30°C (59° – 86°F)
- protect contents from moisture
Inactive Ingredients
caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid, and talc
Questions Or Comments?
Call 1-800-231-4670 Monday-Friday 9AM-5PM EST
Other
*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, owner of the registered trademark FiberCon®.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Package Label.Principal Display Panel
MAJOR®
NDC 0904-2500-91
*compare to the active ingredient in FiberCon®
fiber-tabs
calcium polycarbophil 625 mg
bulk-forming laxative
- safe and effective relief of occasional constipation
- promotes regularity
90 caplets
Major Label (0339 90g Major A3 Lbl R53988)
* Please review the disclaimer below.
