Label: FIBER CAPLETS- calcium polycarbophil tablet, film coated
- NDC Code(s): 21130-021-40
- Packager: SAFEWAY
- 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 October 8, 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 your 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.
- 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.
adults & 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
- INACTIVE INGREDIENT
- Questions or Comments?
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredients of Fibercon® Caplets*
- Gentle Relief of Constipation
- Won’t Cause Gas or Bloating
- Effective as Fiber Powders
*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets.
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-021 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 CALCIUM CARBONATE (UNII: H0G9379FGK) CARAMEL (UNII: T9D99G2B1R) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color BROWN (light) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code RP120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-021-40 140 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/02/2020 Labeler - SAFEWAY (009137209)