Label: LEADER FIBER- calcium polycarbophil tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 53808-0963-1 - Packager: State of Florida DOH Central Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 37205-213
- 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.
Drug Label Information
Updated March 3, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Do not use if
- you have abdominal pain, nausea or vomiting
- you have difficulty in swallowing
- you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.
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
- rectal bleeding occurs
- symptoms persist more than 1 week
Drug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic
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Directions
- take this product (child or adult dose) with a full glass of water (8oz)
- daily maximum 4 doses
- dosage may 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
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adults and 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 ingredients
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
LEADER FIBER
calcium polycarbophil tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0963(NDC:37205-213) 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 (UNII: 68401960MK) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color BROWN (light) Score 2 pieces Shape CAPSULE (caplet) Size 19mm Flavor Imprint Code RP120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0963-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/01/2014 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0963)
