Label: FIBER- calcium polycarbophil tablet, film coated
- NDC Code(s): 55312-477-75
- Packager: Western Family Foods Inc
- 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 September 27, 2012
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- Active ingredient (in each caplet)
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophilClose
- relieves occasional constipation to help restore and maintain regularity
- 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 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. (1-800-222-1222)
- 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.
- this product 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.
- 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
- Other information
- each caplet contains: calcium 140 mg and magnesium 10 mg
- store at 20-25 oC (68-77 oF)
- Inactive ingredients
caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfateClose
- Principal Display Panel
CALCIUM POLYCARBOPHIL 625 mg
FIBER THERAPY FOR REGULARITY
GENTLE ENOUGH FOR EVERYDAY USE
JUST AS EFFECTIVE AS FIBER POWDERS
COMPARE TO FIBERCON® active ingredient
- INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-477 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) CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color BROWN (light) Score 2 pieces Shape CAPSULE (caplet) Size 19mm Flavor Imprint Code L477 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-477-75 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/19/1998 Labeler - Western Family Foods Inc (192166072)