Label: FIBER LAXATIVE- calcium polycarbophil tablet
- NDC Code(s): 54257-379-07
- Packager: Magno-Humphries, 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 November 25, 2020
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- Drug Facts
- Active ingredient (in each tablet)
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
- difficulty in swallowing
- 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 b y a doctor
Stop use and ask a doctor if
- you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
- you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
- take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
- dosage will vary according to diet, exercise, previous laxative use or severity of constipation
- continued use for 1 to 3 days is normally required to provide full benefit
- adults and children 12 years of age and over: 2 tablets once a day up to 4 times a day
- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54257-379 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color white (Off-white) Score no score Shape OVAL Size 20mm Flavor Imprint Code G147 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54257-379-07 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/24/2020 Labeler - Magno-Humphries, Inc. (063251433)