Label: FIBER LAXATIVE- calcium polycarbophil tablet, film coated
- NDC Code(s): 57896-459-09
- Packager: Geri-Care Pharmaceutical Corp
- 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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- Active ingredient (in each caplet)
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
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 laxative 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 and children 12
years of age and older
Starting dose: 2 caplets once a day
Maximum dose: 2 caplets four times a day or as directed by a doctor
children under 12 years of age consult a doctor
- Other information
- Inactive ingredients
- Package Label
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-459 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 LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM CARBONATE (UNII: H0G9379FGK) MALTODEXTRIN (UNII: 7CVR7L4A2D) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) CARAMEL (UNII: T9D99G2B1R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color white (Off white to cream) Score 2 pieces Shape OVAL (Caplet) Size 19mm Flavor Imprint Code CPC;339 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-459-09 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2004 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)