Label: FIBER THERAPY- calcium polycarbophil tablet
- NDC Code(s): 49035-147-94
- Packager: Wal-Mart Stores, 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 August 8, 2018
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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
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- take this product (child or adult dose) with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. 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 and over 2 caplets, 1 to 4 times a day children under 12 years ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-147 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, UNSPECIFIED (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 CAPSULE Size 18mm Flavor Imprint Code G147 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-147-94 140 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 11/01/2013 Labeler - Wal-Mart Stores, Inc. (051957769)