Label: FIBERCON- calcium polycarbophil tablet
- NDC Code(s): 0005-2500-02, 0005-2500-23, 0005-2500-33
- Packager: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
- 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.
Updated November 28, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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
DOSAGE & ADMINISTRATION
- 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.
age recommended dose daily maximum adults and children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL - 36 Caplet Blister Pack Carton
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0005-2500 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:0005-2500-02 9 in 1 CARTON 01/05/2004 1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0005-2500-33 1 in 1 CARTON 01/05/2004 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0005-2500-23 140 in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/05/2004 Labeler - Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)