Dulcolax Pink Stimulant Laxative

Dulcolax Pink Stimulant Laxative
SPL v5
SPL
SPL Set ID fb5ad666-57b3-4b95-b5de-9db5d265925e
Route
ORAL
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Carnauba Wax Starch, Corn D&c Red No. 27 Fd&c Blue No. 2 Fd&c Yellow No. 6 Hypromellose, Unspecified Ferric Oxide Red Lactose, Unspecified Form Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone Propylene Glycol Propylparaben Shellac Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate Dimethicone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: DL Shape: round Color: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-21

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

Principal

Dulcolax

Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative


Pink

OVERNIGHT LAXATIVE


25


COMFORT COATED


TABLETS

Directions

take with a glass of water

adults and children 12 years of age 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
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.

If Pregnant Or B

ask a health professional before use.

Other Information

● contains FD&C Yellow No. 6

● do not use if individual blister unit is open or torn

● store at 20°-25°C (68°-77°F)  

● protect from excessive humidity

Inactive Ingredients

acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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

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

Principal (PRINCIPAL)

Dulcolax

Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative


Pink

OVERNIGHT LAXATIVE


25


COMFORT COATED


TABLETS

Directions

take with a glass of water

adults and children 12 years of age 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
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.

If Pregnant Or B (If pregnant or b)

ask a health professional before use.

Other Information (Other information)

● contains FD&C Yellow No. 6

● do not use if individual blister unit is open or torn

● store at 20°-25°C (68°-77°F)  

● protect from excessive humidity

Inactive Ingredients (Inactive ingredients)

acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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

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

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