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Leader Fiber

Cardinal Health

Leader Fiber Caplets Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

Leader Fiber Uses

relieves:

  • constipation
  • helps restore & maintain regularity
  • promotes normal function of the bowel

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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
  • 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

Leader Fiber Other information

  • each caplet contains: calcium 122 mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • protect contents from moisture

Inactive ingredients

calcium carbonate, caramel, crospovidone, hypromellose, maltodextrin, microcrystalline cellulose, magnesium stearate, methylcellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Principal Display Panel

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

Leader Fiber
Leader Fiber Caplets Label

Leader Fiber

Calcium polycarbophil TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-213
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM POLYCARBOPHIL 625 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
CARAMEL
CROSPOVIDONE
HYPROMELLOSE 2208 (100 MPA.S)
maltodextrin
cellulose, microcrystalline
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 200
SILICON DIOXIDE
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
BROWN (light) 19 mm RP120 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-213-75 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-05-02


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Be sure to consult your doctor before taking any medication!
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