Label: FIBERCON- calcium polycarbophil tablet
- NDC Code(s): 80070-500-14, 80070-500-90
- Packager: Foundation Consumer Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 9, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
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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 lasts 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.
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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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Carton
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INGREDIENTS AND APPEARANCE
FIBERCON
calcium polycarbophil tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80070-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color BROWN Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code LL;F1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80070-500-14 1 in 1 CARTON 04/15/2021 1 140 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:80070-500-90 1 in 1 CARTON 04/15/2021 2 90 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/15/2021 Labeler - Foundation Consumer Brands (117603632)