SPL v1
SPL
SPL Set ID f9fd3251-a652-4291-8248-10adba67ab69
Route
ORAL
Published
Effective Date 2025-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Aluminum Lake Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Methacrylic Acid Polydextrose Polyethylene Glycol, Unspecified Shellac Dimethicone Sodium Bicarbonate Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01
Description

Bisacodyl 5 mg

Purpose

Stimulant laxative

Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl 5 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours
Directions
  • 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 take 1 tablet in a single daily dose
children under 6 years ask a doctor

Do Not Use

if you cannot swallow without chewing.

Questions?

call toll-free 1-844-912-4012

Other Information
  • do not use if seal around tablet is broken or damaged
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

Principal Display Panel

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, and cramps
Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Bisacodyl 5 mg

Ask A Doctor Before Use If You Have
  • a sudden change in bowel habits that lasts more than 2 weeks
  • stomach pain, nausea or vomiting

Structured Label Content

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

Stimulant laxative

Directions
  • 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 take 1 tablet in a single daily dose
children under 6 years ask a doctor

Do Not Use (Do not use)

if you cannot swallow without chewing.

Questions?

call toll-free 1-844-912-4012

Other Information (Other information)
  • do not use if seal around tablet is broken or damaged
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

Principal Display Panel (Principal display panel)

When Using This Product (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, and cramps
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
  • you need to use a laxative for more than 1 week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sudden change in bowel habits that lasts more than 2 weeks
  • stomach pain, nausea or vomiting

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.463393 · Updated: 2026-03-14T23:09:50.407692