FDA.reportPublic FDA data

WOMENS GENTLE LAXATIVE

Manufacturer
CVS HEALTH CORP | TIME CAP LABORATORIES, INC.
Effective date
2025-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:16

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Bisacodyl USP, 5 mg

OTC - PURPOSE SECTION

Purpose Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions take with a glass of water adults and children 12 years of age and over 1 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 age ask a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 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

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Label Images#

151R- CVS 25ct
151R- CVS 25ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN3
308753bisacodyl 5 MG Delayed Release Oral TabletSCD3
308753bisacodyl 5 MG Enteric Coated Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-089-522025-02-13C16284748780-12cef2736-b559-d83d-e063-dadaa90ab31f151R CVS BISACODYL WOMEN'S GENTLE LAXATIVE 69842-089
69842-089-522025-01-30C16284748780-12cef2736-b559-d83d-e063-dadaa90ab31f151R CVS BISACODYL WOMEN'S GENTLE LAXATIVE 69842-089

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-089-52WOMENS GENTLE LAXATIVE25 in 1 BLISTER PACKTABLET, COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-089WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [CVS HEALTH CORP]3Current NDC, Legacy NDC, 1 package rows20250215_a95073f3-e1d6-d291-e053-2a95a90aefea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-089-52EA - Each69842-089e775cf63-9fb0-49ba-b1fc-e4ae339d76c012022-09-12

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-08969842-089-52

Ingredients#

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
MAGNESIUM STEARATE70097M6I30IACT
BISACODYL10X0709Y6IACTIB
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STARCH, CORNO8232NY3SJIACT
GELATIN2G86QN327LIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
SHELLAC46N107B71OIACT
STEARIC ACID4ELV7Z65APIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POVIDONEFZ989GH94EIACT
ACACIA5C5403N26OIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
IRON OXIDES1K09F3G675IACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Bisacodyl USP, 5 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Stimulant laxative

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

WARNINGS SECTION

Warnings

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions take with a glass of water adults and children 12 years of age and over 1 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 age ask a doctor

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 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

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Source Document#

Source XML