WOMENS LAXATIVE ENTERIC COATED

Manufacturer
CARDINAL HEALTH | TIME CAP LABORATORIES, INC. | TIME CAP LABORATORIES, INC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:09

Label at a glance#

ProductWOMENS LAXATIVE ENTERIC COATED
Active ingredientBISACODYL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each tablet: Bisacodyl 5mg

OTC - PURPOSE SECTION

Stimulant Laxative

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useif 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 two weeks

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

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

  • take with a glass of water

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25ct25ct

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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0570-1WOMENS LAXATIVE ENTERIC COATED25 in 1 BLISTER PACKTABLET, COATED253
70000-0570-1WOMENS LAXATIVE ENTERIC COATED1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0570WOMENS LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [CARDINAL HEALTH]3Current NDC, Legacy NDC, 2 package rows20240113_ab34bc89-6738-d284-e053-2a95a90a5dc9.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-057070000-0570-1

Ingredients#

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

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

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 LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
ndc (package): 70000-0570-1
ndc (product): 70000-0570
ndc11 (package): 70000057001
spl id: 0eaa0deb-1a55-deb7-e063-6294a90a21e5
spl set id: ab34bc89-6738-d284-e053-2a95a90a5dc9

Reported adverse events (FAERS/openFDA)#

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