FDA.reportPublic FDA data

Womens Gentle Laxative

Manufacturer
RETAIL BUSINESS SERVICES, LLC
Effective date
2023-05-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:54

Label at a glance#

ProductWomens Gentle Laxative
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Dosage and administration

adults and children 12 years 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

Storage and handling

store at 20-25°C (68-77°F) protect from excessive humidity

Label contents#

Full prescribing information#

Active Ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl (USP) 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

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
  • a sudden change in bowel habits that lasts more than 2 weeks

OTC - WHEN USING SECTION

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • 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 no 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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over1 to 3 tablets in a single daily dose
children 6 to under 12 years of age1 tablet in a single daily dose
children under 6 years of ageask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose monohydrate, D&C Red #27, FD&C Blue #1, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, methacrylic acid copolymer, methyl cellulose, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Carton

Women Lax 25 ctWomen Lax 25 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-960-252025-01-30C16284748780-12cef2736-9f41-d83d-e063-dadaa90ab31fWomen's Gentle Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-960-25Womens Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE14
72476-960-25Womens Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-960WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [RETAIL BUSINESS SERVICES, LLC]4Legacy NDC, 2 package rows20230510_a8962015-acfa-4f28-b3da-250622b9de5f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-96072476-960-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW)WR7H9IW2XXIACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
STARCH, POTATO8I089SAH3TIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
BISACODYL10X0709Y6IACTIB

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
fab92744-47ce-24d2-e053-6394a90ab03ba8962015-acfa-4f28-b3da-250622b9de5f2023-05-02WarningsExact identifier
spl id: fab92744-47ce-24d2-e053-6394a90ab03b
spl set id: a8962015-acfa-4f28-b3da-250622b9de5f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.