Fibercon Tablet
FDA Label NDC 80070-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Brands for the product Fibercon (NDC 80070-500). 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 other, active ingredient (in each caplet), purpose, uses, choking, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

Active Ingredient (In Each Caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Uses

  • relieves occasional constipation (irregularity)
  • 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 lasts over a period of 2 weeks

Otc - Ask Doctor/Pharmacist

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.

Otc - When Using

When using this product do not use for more than 7 days unless directed by a doctor

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

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.
  • FiberCon works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
  • adults and children 12 years of age and over: 2 caplets per dose. Do not take more than 8 caplets in 24 hours unless directed by a doctor.
  • children under 12 years of age: ask a doctor

Other Information

  • each caplet contains: 140 mg calcium and 10 mg magnesium
  • protect contents from moisture
  • store at 20-25°C (68-77°F)

Inactive Ingredients

caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Questions Or Comments?

Call 1-888-594-0677 weekdays 9 AM to 5 PM EST

Principal Display Panel - 90 Caplet Bottle Carton

FiberCon®

Calcium Polycarbophil
Bulk-Forming Laxative

Fiber Therapy for Irregularity

90 Caplets

Principal Display Panel (90 Caplet Bottle Carton)

Principal Display Panel (90 Caplet Bottle Carton)

* Please review the disclaimer below.