Label: FIBER CAPLETS- calcium polycarbophil tablet
- NDC Code(s): 49348-190-13
- Packager: Strategic Sourcing Services LLC
- 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 18, 2019
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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
- 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 caplets in a 24 hour period unless directed by 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, excercise, previous laxative use or severity of constipation.
- continued use for 1 or 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
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-190 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARAMEL (UNII: T9D99G2B1R) Product Characteristics Color white Score no score Shape capsule Size 19mm Flavor Imprint Code G147 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-190-13 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/18/2019 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Guardian Drug Company (119210276) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 manufacture(49348-190)