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

Label at a glance#

ProductWOMENS GENTLE LAXATIVE
Active ingredientBISACODYL
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

OTC - PURPOSE SECTION

Purpose

Stimulant laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • if you cannot swallow without chewing

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

151R- CVS 25ct151R- 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#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

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

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

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

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
ndc (package): 69842-089-52
ndc (product): 69842-089
ndc11 (package): 69842008952
spl id: 2dff3d94-3171-df85-e063-6294a90a05b7
spl set id: a95073f3-e1d6-d291-e053-2a95a90aefea