Dulcolax®

Dulcolax®
SPL v1
SPL
SPL Set ID eac116c1-d109-4c01-8cd4-ba27ddd2ce40
Route
ORAL
Published
Effective Date 2012-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bisacodyl (5 mg)
Inactive Ingredients
Acacia Carnauba Wax Cellacefate Starch, Corn Dibutyl Phthalate Docusate Sodium Gelatin Glycerin Kaolin Lactose Magnesium Stearate Methylparaben Shellac Polyethylene Glycols Povidone Propylparaben Sodium Benzoate Sorbitan Monooleate Sucrose Talc Titanium Dioxide White Wax Diacetylated Monoglycerides Ferric Oxide Red

Identifiers & Packaging

Pill Appearance
Imprint: 12;BI Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-01-01
Description

Drug Facts

Purpose

Stimulant laxative

Medication Information

Purpose

Stimulant laxative

Description

Drug Facts

Use
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use if you cannot swallow without chewing

Section 53414-9

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

Questions

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

Directions

take with a glass of water

adults and children 12 years and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years of age ask a doctor
Other Information
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity
Inactive Ingredients

acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

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 no 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
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
Principal Display Panel 5 Mg Pouch Package

CONVENIENCE

CV

VALET®

DRINKING CUP

INCLUDED

Dulcolax ®

LAXATIVE

(bisacodyl USP 5 mg)

C6A

3 TABLETS

Structured Label Content

Use
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use if you cannot swallow without chewing

Section 53414-9 (53414-9)

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

Purpose

Stimulant laxative

Questions

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

Directions

take with a glass of water

adults and children 12 years and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years of age ask a doctor
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

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 no 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
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
Principal Display Panel 5 Mg Pouch Package (PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package)

CONVENIENCE

CV

VALET®

DRINKING CUP

INCLUDED

Dulcolax ®

LAXATIVE

(bisacodyl USP 5 mg)

C6A

3 TABLETS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:25.120382 · Updated: 2026-03-14T22:53:00.263233