SPL v1
SPL
SPL Set ID af2dbf50-f7ac-486d-a636-f8f77d7c880f
Route
ORAL
Published
Effective Date 2025-01-22
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 Water 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 2025-01-01
Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 51945-4

NDC 80513-409-20

*Compare to Dulcolax ® Laxative Tablets Active Ingredient

Laxative

Bisacodyl USP 5 mg

Gentle Predictable

Overnight Relief

200 Comfort Coated Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Dulcolax ®.

Directions
  • do not take more than directed
  • 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.

Distributed By

ADVANCED RX LLC

1942 NE 163rd St.North Miami Beach,

FL 33162 U.S.A.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • use by expiration date on package
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, Purified Water, Sodium Starch Glycolate, Talc, Titanium Dioxide, Triethyl citrate.

Questions Or Comments?

1-800-630-8895

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 use of a laxative. 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 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 relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 51945-4 (51945-4)

NDC 80513-409-20

*Compare to Dulcolax ® Laxative Tablets Active Ingredient

Laxative

Bisacodyl USP 5 mg

Gentle Predictable

Overnight Relief

200 Comfort Coated Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Dulcolax ®.

Purpose

Stimulant laxative

Directions
  • do not take more than directed
  • 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.

Distributed By (Distributed by)

ADVANCED RX LLC

1942 NE 163rd St.North Miami Beach,

FL 33162 U.S.A.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • use by expiration date on package
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, Purified Water, Sodium Starch Glycolate, Talc, Titanium Dioxide, Triethyl citrate.

Questions Or Comments? (Questions or comments?)

1-800-630-8895

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 use of a laxative. 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 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: 2026-02-15T12:05:24.051155 · Updated: 2026-03-14T23:07:07.673818