Dulcolax Stool Softener - Patheon

SPL v7

SPL

SPL Set ID 86cb7102-3585-4757-9c37-5bf9776bbe63

Route

ORAL

Published

Effective Date 2025-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Mannitol Polyethylene Glycol 400 Propylene Glycol Sorbitan Sorbitol Water

Identifiers & Packaging

Pill Appearance

Imprint: Dulcolax Shape: oval Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-08-01 Until 2024-09-18

Description

Dulcolax® Stool Softener Carton Drug Facts

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Dulcolax® Stool Softener Carton Drug Facts

Use

● for relief of occasional constipation and irregularity

● this product generally produces bowel movement in 12 to 72 hours

Section 42229-5

Dulcolax®

Stool Softener Carton

Drug Facts

Directions

take with a glass of water
adults and children 12 years of age and over	1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age	1 capsule daily
children under 2 years of age	ask a doctor

Do Not Use

● if you are presently taking mineral oil, unless told to do so by a doctor

Questions?

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

Keep carton as it contains important product information.

Other Information

● each capsule contains: sodium 6 mg

● store at 20-25°C (68-77°F). Protect from excessive humidity

● contains FD&C Yellow No. 6

● do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

Principal Display Panel

Dulcolax

Stool Softener

25 Liquid Gels

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

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 Capsule)

Docusate sodium (USP) 100 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

Use

● for relief of occasional constipation and irregularity

● this product generally produces bowel movement in 12 to 72 hours

Section 42229-5 (42229-5)

Dulcolax®

Stool Softener Carton

Drug Facts

Purpose

Stool softener laxative

Directions

take with a glass of water
adults and children 12 years of age and over	1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age	1 capsule daily
children under 2 years of age	ask a doctor

Do Not Use (Do not use)

● if you are presently taking mineral oil, unless told to do so by a doctor

Questions?

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

Keep carton as it contains important product information.

Other Information (Other information)

● each capsule contains: sodium 6 mg

● store at 20-25°C (68-77°F). Protect from excessive humidity

● contains FD&C Yellow No. 6

● do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dulcolax

Stool Softener

25 Liquid Gels

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

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 Capsule) (Active ingredient (in each capsule))

Docusate sodium (USP) 100 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

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "● for relief of occasional constipation and irregularity ● this product generally produces bowel movement in 12 to 72 hours", "42229-5": "Dulcolax® Stool Softener Carton Drug Facts", "Purpose": "Stool softener laxative", "Directions": "take with a glass of water adults and children 12 years of age and over 1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age 1 capsule daily children under 2 years of age ask a doctor", "Do not use": "● if you are presently taking mineral oil, unless told to do so by a doctor", "Questions?": "Call 1-866-844-2798 or visit www.Dulcolax.com Keep carton as it contains important product information.", "Other information": "● each capsule contains: sodium 6 mg ● store at 20-25°C (68-77°F). Protect from excessive humidity ● contains FD&C Yellow No. 6 ● do not use this product if the safety seal under the cap is torn or missing", "Inactive ingredients": "FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water", "PRINCIPAL DISPLAY PANEL": "Dulcolax Stool Softener 25 Liquid Gels", "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", "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 capsule)": "Docusate sodium (USP) 100 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:47.061491 · Updated: 2026-03-14T23:09:45.619768