BISACODYL- bisacodyl tablet, coated 
KROGER COMPANY

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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KROGER 14R BISACODYL 5 MG TABLETS 41226-003

Active ingredeint (in each tablet)

Bisacodyl 5 mg

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Stimulant Laxative

Uses:

relieves occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

DOSAGE & ADMINISTRATION


Warnings

Keep Out of Reach of Children
Keep out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away.

25 ct

BISACODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SUCROSE (UNII: C151H8M554)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STARCH, CORN (UNII: O8232NY3SJ)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ACACIA (UNII: 5C5403N26O)  
TALC (UNII: 7SEV7J4R1U)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-003-5225 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/01/2020
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS037052099manufacture(41226-003)

Revised: 6/2020
Document Id: a706c6a6-e716-9044-e053-2995a90a95dc
Set id: a13a8eec-3652-8c57-e053-2995a90aaebf
Version: 2
Effective Time: 20200601
 
KROGER COMPANY