Label: LEADER FIBER- calcium polycarbophil tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-213-75 - Packager: Cardinal Health
- 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 February 10, 2021
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
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- you have abdominal pain, nausea or vomiting
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- you have difficulty in swallowing
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- 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
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- you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
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- you fail to have a bowel movement after use
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- rectal bleeding occurs
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- 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
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- take this product (child or adult dose) with a full glass of water (8oz)
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- daily maximum 4 doses
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- dosage may vary according to diet, exercise, previous laxative use or severity of constipation
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- continued use for 1 to 3 days is normally required to provide full benefit
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
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Principal Display Panel
NDC 30205-213-75
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available
Fiber Caplets
Calcium Polycarbophil 625 mg
Fiber Laxative
Gentle Relief of Constipation
Won't Cause Gas or Bloating
Compare to Fibercon® active ingredient
CIN 2545440
Distributed By:
Cardinal Health
Dublin Ohio 43017
www.myleader.com
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INGREDIENTS AND APPEARANCE
LEADER FIBER
calcium polycarbophil tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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 (15 MPA.S AT 5%) (UNII: 68401960MK) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) 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:37205-213-75 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/19/2019 Labeler - Cardinal Health (097537435)
