SPL v1
SPL
SPL Set ID afb39544-c509-490c-ad42-ba68ebbf986b
Route
ORAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Maltodextrin Methacrylic Acid Microcrystalline Cellulose D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Polyethylene Glycol 400 Sodium Starch Glycolate Type A Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: B5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-28
Description

Bisacodyl USP, 5 mg

Purpose

Laxative

Medication Information

Purpose

Laxative

Description

Bisacodyl USP, 5 mg

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Directions
  • take with a glass of water
adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years   1 tablets once a day
children under 6 years  ask a doctor

Do Not Use

if you cannot swallow without chewing

Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before use.
Inactive Ingredients

Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Questions Or Comments?

Call + 1-848-235-5293

Monday through Friday 9AM – 5PM EST

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
  • it may cause stomach discomfort, faintness, and cramps
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
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 USP, 5 mg

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

Structured Label Content

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

Laxative

Directions
  • take with a glass of water
adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years   1 tablets once a day
children under 6 years  ask a doctor

Do Not Use (Do not use)

if you cannot swallow without chewing

Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before use.
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Questions Or Comments? (Questions or comments?)

Call + 1-848-235-5293

Monday through Friday 9AM – 5PM EST

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
  • it may cause 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 using this product. These could 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 USP, 5 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:38.742810 · Updated: 2026-03-14T23:09:31.593516