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Leader Fiber by State of Florida DOH Central Pharmacy

Medically reviewed on March 5, 2018

Dosage form: tablet, film coated
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: State of Florida DOH Central Pharmacy
NDC Code: 53808-0963

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.

Leader Fiber Caplets Drug Facts

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 over2 caplets once a dayup to 4 times a day
    children under 12 yearsconsult 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

LEADER FIBER 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0963(NDC:37205-213)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
CARAMEL 
CROSPOVIDONE 
HYPROMELLOSE 2208 (100 MPA.S) 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 200 
COLLOIDAL SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorBROWN (light) Score2 pieces
ShapeCAPSULE (caplet) Size19mm
FlavorImprint CodeRP120
Contains    
Packaging
#Item CodePackage Description
1NDC:53808-0963-130 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/01/2014
Labeler - State of Florida DOH Central Pharmacy (829348114)
Establishment
NameAddressID/FEIOperations
State of Florida DOH Central Pharmacy829348114repack(53808-0963)

 
State of Florida DOH Central Pharmacy

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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