LEADER FIBER - calcium polycarbophil tablet, film coated 
State of Florida DOH Central Pharmacy

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.

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Leader Fiber Caplets Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

Uses

relieves:

Warnings

Do not use if

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

Other information

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

Label Image for 625mg
LEADER FIBER 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0963(NDC:37205-213)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (light) Score2 pieces
ShapeCAPSULE (caplet) Size19mm
FlavorImprint Code RP120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53808-0963-130 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/FEIBusiness Operations
State of Florida DOH Central Pharmacy829348114repack(53808-0963)

Revised: 3/2014
Document Id: ce8f069a-db9a-4f98-856f-cccc4fb48d45
Set id: e7d790fb-5dfc-4628-a70b-f617581e1ee6
Version: 1
Effective Time: 20140303
 
State of Florida DOH Central Pharmacy