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 State of Florida DOH Central Pharmacy. 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

PACKAGE LABEL

Distributed By:

Cardinal Health

Dublin Ohio 43017

www.myleader.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

Label Image for 53808-0963
625mg

INGREDIENTS AND APPEARANCE

LEADER FIBER 
calcium polycarbophil tablet, film coated

Product 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)