GENTLE LAXATIVE- bisacodyl tablet, delayed release 
BETTER LIVING BRANDS 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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14R_Albertsons_21130-410_Bisacodyl Delayed Release Tablets 5 mg

Drug Facts

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

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 12 years of age and over1 to 3 tablets in a single daily dose
children 6 to under 12 years of age

1 tablet in a single daily dose

children under 6 years of ageask a doctor

Other information

Inactive ingredients acacia, 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 phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments? 1-877-290-4008

14R_Albertsons_21130-410-20_LBL14R_Albertsons_21130-410-52_IFC

GENTLE LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-410
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ACACIA (UNII: 5C5403N26O)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-410-521 in 1 CARTON06/01/2023
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:21130-410-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/01/2023
Labeler - BETTER LIVING BRANDS LLC. (009137209)
Registrant - Time Cap Labs Inc. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(21130-410)

Revised: 6/2023
Document Id: ff5391d0-d0dc-6f42-e053-6394a90aae9b
Set id: f29d57f6-0938-d459-e053-2995a90ad86b
Version: 2
Effective Time: 20230601
 
BETTER LIVING BRANDS LLC.