EXTRA GENTLE LAXATIVE- bisacodyl tablet, delayed release 
DOLGENCORP INC

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.

----------

14R Dollar General 55910 954 Bisacodyl Delayed-Release USP,5mg ct25

DRUG FACTS

Active ingredient
(in each tablet)
Bisacodyl USP 5 mg

Purpose
Stimulant laxative

Uses

Warnings

Do not use if you cannot swallow without chewing

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.

Directions

adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age: take 1 tablet in a single daily dose
children under 6 years of age:ask a doctor

OTHER INFORMATION

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? Call 1-888-309-9030

14R-DOLGENCORP-BISACODYL Delayed-Release USP 5mg-carton.jpg

EXTRA GENTLE LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-954
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
GELATIN (UNII: 2G86QN327L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
ACACIA (UNII: 5C5403N26O)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
INVERT SUGAR (UNII: ED959S6ACY)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-954-521 in 1 CARTON07/24/2021
125 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 finalpart33407/24/2021
Labeler - DOLGENCORP INC (068331990)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(55910-954)

Revised: 7/2021
Document Id: c79f24d5-7cc1-6e65-e053-2995a90a0b96
Set id: be214c4e-f6db-cc8d-e053-2a95a90addf7
Version: 2
Effective Time: 20210721
 
DOLGENCORP INC