FDA.reportPublic FDA data

Bisacodyl 5mg

Manufacturer
Allegiant Health
Effective date
2017-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:09:46

Label at a glance#

ProductBisacodyl 5mg
Active ingredientBISACODYL
Label structure8 sections

Indications and uses

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

Dosage and administration

take with water  Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily Children 6 to 12 years of age: take 1 tablet once a day Children under 6 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are unable to swallow without chewing
  • within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • do not chew or crush tablets
  • abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use more than 1 week
  • rectal bleeding or failure to have a bowel movement after use of a laxative.

These may be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with water 

Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily

Children 6 to 12 years of age: take 1 tablet once a day

Children under 6 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store between 68º to 77ºF (20º to 25ºC)
  • do not use blister unit is broken or torn
  • Calcium content: 16.33mg per tablet

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium sulfate anhydrous, carnauba wax, corn starch, D&C red #7 calcium lake, hypromellose phthalate, iron oxide black, iron oxide red, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, shellac, silicon dioxide, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HealthA2Z®

Compare to Correctol® active ingredient*

Woman's Gentle 

Laxative

BISACODYL STIMULANT LAXATIVE 5mg

For Gentle, Reliable 

Overnight Relief

(double pill image)

Tablets

Woman's Laxative 30ct. Tablets
Woman's Laxative 30ct. Tablets

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-23269168-232-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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
1eb9d763-ed59-4e57-bae6-677e8311cc142d8defb6-280a-4e63-a54a-19fd90fe54982017-11-16WarningsExact identifier
spl set id: 2d8defb6-280a-4e63-a54a-19fd90fe5498

Reported adverse events (FAERS/openFDA)#

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