FIBER LAXATIVE CAPLETS- calcium polycarbophil tablet 
Gendose Pharmaceuticals, LLC

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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GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)

ACTIVE INGREDIENT (IN EACH CAPLET)

CALCIUM POLYCARBOPHIL 625 MG

(EQUIVALENT TO 500 MG POLYCARBOPHIL)

PURPOSE

BULK-FORMING LAXATIVE

USES

WARNINGS

CHOKING: TAKING THIS PRODUCT WITHOUT ADEQUATE FLUID MAY CAUSE IT TO SWELL AND BLOCK YOUR THROAT OR ESAPHAGUS AND MAY CAUSE CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE DIFFICULATY 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 DRUGS WORK.

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF RECTAL BLEEDING OCCURS OR IF YOU FAIL TO HAVE A BOWEL MOVEMENT AFTER USE OF THIS OR ANY OTHER LAXATIVES. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY 1-800-222-1222.

DIRECTIONS

ADULTS AND CHILDREN OVER 12 YEARS: 2 CAPLETS ONCE A DAY; UP TO 4 TIMES A DAY.

CHILDREN UNDER 12 YEARS: ASK A DOCTOR

OTHER INFORMATION

INACTIVE INGREDIENTS

CALCIUM CARBONATE, CARAMEL COLOR, CROSPOVIDONE, HYPROMELLOSE, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SILICON DIOXIDE, SODIUM LAURYL SULFATE

01b LBL_Fiber Laxative Caplets_50 caplets

FIBER LAXATIVE CAPLETS 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-120
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CROSPOVIDONE (UNII: 2S7830E561)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARAMEL (UNII: T9D99G2B1R)  
Product Characteristics
Colorbrown (mottled light-brown color with dark specs) Scoreno score
ShapeOVAL (CAPLET) Size19mm
FlavorImprint Code RP120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77333-120-5050 in 1 BOX09/02/2022
1NDC:77333-120-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/02/2022
Labeler - Gendose Pharmaceuticals, LLC (080257510)

Revised: 11/2022
Document Id: edb25ecf-b7f4-9663-e053-2995a90a8534
Set id: e7f3b91b-7942-3e0d-e053-2a95a90a34ee
Version: 5
Effective Time: 20221117
 
Gendose Pharmaceuticals, LLC