SPL v1
SPL
SPL Set ID 02358772-6724-4f1a-b3d8-bc36e58b5cfc
Route
ORAL
Published
Effective Date 2025-06-23
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 Cellulose, Microcrystalline 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 2025-05-01
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
Section 42229-5

Distributed by

BI-MART

Eugene, OR 97402

Section 51945-4

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 of age  take 1 tablet in a single daily dose
children under 6 years of age ask a doctor

Do Not Use

if you cannot swallow without chewing

Questions?

call toll-free 1-844-912-4012

Other Information
  • store at 20°-25°C (68°-77°F)
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.

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
Section 42229-5 (42229-5)

Distributed by

BI-MART

Eugene, OR 97402

Section 51945-4 (51945-4)

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 of age  take 1 tablet in a single daily dose
children under 6 years of age 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)
  • store at 20°-25°C (68°-77°F)
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.

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: 2026-02-15T12:06:22.703914 · Updated: 2026-03-14T23:09:06.809873