GENTLE LAXATIVE- bisacodyl tablet 
WinCo Foods 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.

----------

14R Winco Foods 67091 385 Bisacodyl USP 5mg 25 count

DRUG FACTS

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

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

Warnings

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product

• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

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
each tablet contains: magnesium 5 mg
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
• protect from excessive humidity

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

Comments & Questions? 800-824-1706

014R-Winco-Gentle-lax-carton-label-24s

GENTLE LAXATIVE 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-385
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
GELATIN (UNII: 2G86QN327L)  
SUCROSE (UNII: C151H8M554)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SHELLAC (UNII: 46N107B71O)  
ACACIA (UNII: 5C5403N26O)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-385-251 in 1 CARTON01/12/2022
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 finalpart33401/12/2022
Labeler - WinCo Foods LLC (056098817)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(67091-385)

Revised: 1/2022
Document Id: d4e989df-015f-4ee0-e053-2995a90a34e0
Set id: c34db60b-bbea-770f-e053-2a95a90a36da
Version: 2
Effective Time: 20220106
 
WinCo Foods LLC