WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated 
CVS HEALTH CORP

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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151R CVS BISACODYL WOMEN'S GENTLE LAXATIVE 69842-089

ACTIVE INGREDIENT
In each tablet: Bisacodyl 5mg

In each tablet: Bisacodyl 5mg

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C red #27, FD&C blue#2 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

PURPOSE
Stimulant Laxative

Stimulant Laxative

Uses:

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

DOSAGE & ADMINISTRATION
adults and children 12 years and over: take 1 to 3 tablets in a single daily dose -

children 6 to under 12 years: take 1 tablet in a single daily dose -

children under 6 years: ask a doctor


Keep out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Warning: 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 two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

25 CT

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-089
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
GELATIN (UNII: 2G86QN327L)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
SHELLAC (UNII: 46N107B71O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-089-5225 in 1 BLISTER PACK; Type 0: Not a Combination Product08/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/24/2020
Labeler - CVS HEALTH CORP (062312574)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(69842-089)

Revised: 8/2020
Document Id: ad9f82c7-c0d4-9ca7-e053-2a95a90a391a
Set id: a95073f3-e1d6-d291-e053-2a95a90aefea
Version: 2
Effective Time: 20200824
 
CVS HEALTH CORP