Label: FIBER TABS- calcium polycarbophil tablet, film coated
- NDC Code(s): 0904-2500-91
- Packager: Major Pharmaceuticals
- 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 May 18, 2020
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- Drug Fats
Choking Warning: 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 tablets 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.
Take 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
• adults & children over 12 years of age: take 2 tablets 1 to 4 times a day
• children under 12 years of age: consult a physician
- OTHER INFORMATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2500 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARAMEL (UNII: T9D99G2B1R) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (Off white) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code CPC;339 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-2500-91 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2010 Labeler - Major Pharmaceuticals (191427277)