FIBER LAXATIVE- calcium polycarbophil tablet 
CARDINAL HEALTH 110, LLC. DBA LEADER

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 Laxative

WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food. 

ACTIVE INGREDIENT (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

PURPOSE

Bulk-forming laxative

USE(S)

WARNINGS

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

In case of over dose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS


adults and children 12 years and over2 caplets, 1 to 4 times a day 
 children under 12 years  ask a doctor







OTHER INFORMATION

INACTIVE INGREDIENTS

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

LEADER
NDC 70000-0432-1

Fiber
Laxative

Calcium Polycarbophil, 625mg
Bulk-Forming Laxative 

Relieves Occasional Constipation

COMPARE TO FIBERCON® active ingredient*

250 CAPLETS


51

FIBER LAXATIVE 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0432
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (Off white) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0432-1250 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/24/2019
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Revised: 1/2022
Document Id: f4daf03f-8b1c-4e76-a8c6-014b03b7e5b6
Set id: c7c9fd97-a028-4682-a1d6-fb874026e2d7
Version: 4
Effective Time: 20220110
 
CARDINAL HEALTH 110, LLC. DBA LEADER