Dulcolax Stimulant Laxative Cmp-cha

Dulcolax Stimulant Laxative Cmp-cha
SPL v8
SPL
SPL Set ID d285651b-7ccc-4ae5-a862-7a38dffefa28
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Glyceryl Monostearate Hypromelloses Ferric Oxide Red Lactose Polyethylene Glycol 6000 Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Starch, Corn Stearic Acid Triethyl Citrate Water

Identifiers & Packaging

Pill Appearance
Imprint: 12 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-12

Description

Dulcolax® Stimulant Laxative Tablets Drug Facts

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Dulcolax® Stimulant Laxative Tablets Drug Facts

Use

● for relief of occasional constipation and irregularity

this product generally produces bowel movement in 6 to 12 hours

Section 42229-5

Dulcolax®

Stimulant Laxative Tablets

Drug Facts

Directions
● Take with a glass of water
adults and children 12 years of age and over start with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose.
children 6 to under 12 years of age 1 tablet per day
children under 6 years of age ask a doctor
Do Not Use

 if you cannot swallow without chewing

Questions?

Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.

Other Information

● store at 20°-25°C (68°-77°F)

● protect from excessive humidity

Inactive Ingredients

glycerol monostearate, hypromellose, iron oxides, lactose, macrogol 6000, magnesium stearate, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, pregelatinized maize starch, stearic acid, triethyl citrate, water

Principal Display Panel

OVERNIGHT RELIEF

Dulcolax

LAXATIVE

25 comfort coated Tablets

When Using This Product

 it may cause stomach discomfort, faintness and cramps

 do not chew or crush tablet(s)

 do not use within 1 hour after taking an antacid or milk

Active Ingredient (in Each

Bisacodyl (USP) 5 mg

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 right away.

Ask A Doctor Before Use If You Have

stomach pain, nausea or vomiting

● noticed a sudden change in bowel habits that lasts more than 2 weeks


Structured Label Content

Use

● for relief of occasional constipation and irregularity

this product generally produces bowel movement in 6 to 12 hours

Section 42229-5 (42229-5)

Dulcolax®

Stimulant Laxative Tablets

Drug Facts

Purpose

Stimulant laxative

Directions
● Take with a glass of water
adults and children 12 years of age and over start with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose.
children 6 to under 12 years of age 1 tablet per day
children under 6 years of age ask a doctor
Do Not Use (Do not use)

 if you cannot swallow without chewing

Questions?

Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.

Other Information (Other information)

● store at 20°-25°C (68°-77°F)

● protect from excessive humidity

Inactive Ingredients (Inactive ingredients)

glycerol monostearate, hypromellose, iron oxides, lactose, macrogol 6000, magnesium stearate, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, pregelatinized maize starch, stearic acid, triethyl citrate, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

OVERNIGHT RELIEF

Dulcolax

LAXATIVE

25 comfort coated Tablets

When Using This Product (When using this product)

 it may cause stomach discomfort, faintness and cramps

 do not chew or crush tablet(s)

 do not use within 1 hour after taking an antacid or milk

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

Bisacodyl (USP) 5 mg

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 right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain, nausea or vomiting

● noticed a sudden change in bowel habits that lasts more than 2 weeks


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)