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

Purpose

Stool softener laxative

Description

Dulcolax® Stool Softener Carton Drug Facts

Medication Information

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

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

Description

Dulcolax® Stool Softener Carton Drug Facts

Principal Display Panel

Dulcolax

Stool Softener

25 Liquid Gels

Questions?

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

Keep carton as it contains important product information.

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

Do Not Use

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

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

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

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

Questions?

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

Keep carton as it contains important product information.

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

Do Not Use (Do not use)

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

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

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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