LEADER FIBER- calcium polycarbophil tablet, film coated

Leader Fiber by

Drug Labeling and Warnings

Leader Fiber by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

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

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

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

Leader Fiber Caplets Label

INGREDIENTS AND APPEARANCE

LEADER FIBER 
calcium polycarbophil tablet, film coated

Product 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)