Label: FIBER TABS- calcium polycarbophil tablet
- NDC Code(s): 0904-2500-91
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 14, 2012
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- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH TABLET)
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophilClose
Bulk-forming fiber laxativeClose
- relieves occasional constipation to help restore and maintain regularity
- this product generally produces bowel movement in 12 to 72 hours
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 caplets 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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.
- Do not take more than 4 doses in 24 hours
age recommended dose daily maximum adults and children 12 years of age and over 2 tablets 1 to 4 times a day children under 12 years consult a physician
- OTHER INFORMATION
- each tablet contains: 140 mg calcium
- protect contents from moisture
- store at room temperature, USP
- do not use if imprinted safety seal under cap is broken or missing
- INACTIVE INGREDIENTS
caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acidClose
- QUESTIONS OR COMMENTS?
To report side effects call: 1-800-616-2471Close
- PRINCIPAL DISPLAY PANEL
Calcium Polycarbophil Bulk-Forming Fiber Laxative
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA
- INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet
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) POLYCARBOPHIL 500 mg Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MAGNESIUM SILICATE (UNII: 9B9691B2N9) LIGHT MINERAL OIL (UNII: N6K5787QVP) 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) Product Characteristics Color GRAY (Off white to grayish color depending on lighting) Score 2 pieces Shape OVAL Size 20mm 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part334 09/09/2010 Labeler - Major Pharmaceuticals (191427277)