Docusate Sodium 250mg - Relabeled Product

Docusate Sodium 250mg - Relabeled Product
SPL v1
SPL
SPL Set ID 050c6139-344b-47d4-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2014-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: P20 Shape: oval Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-20
Description

Active Ingredient (in each softgel) Docusate Sodium 250 mg

Medication Information

Warnings and Precautions

Do not use

•if you are currently taking mineral oil, unless directed by a doctor

•when abdominal pain, nausea, or

vomiting are present

•for more than 1 week, unless directed by a doctor.

Indications and Usage

Uses:

•for the prevention of dry, hard stools

•for relief of occasional constipation

•this product generally produces a bowel movement within 12 to 72 hours.

Description

Active Ingredient (in each softgel) Docusate Sodium 250 mg

Section 34076-0

Directions:

Adults and children 12 years of age and over:

take 1 softgel daily or as directed by a doctor.

Children under 12 years of age: take as directed by doctor.

Other Information:

each softgel contains: sodium 15 mg.

Store between 15-30 C (59-86 F)

Section 50569-3

Ask a doctor before use if:

•you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if:

•you have rectal bleeding

•you fail to have a bowel movement after use. These could be signs of a serious condition.

Section 51727-6

edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Section 51945-4

Section 53414-9

•ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Section 55105-1

Purpose

Stool Softener

Section 55106-9

Active Ingredient (in each softgel)

Docusate Sodium 250 mg

Structured Label Content

Indications and Usage (34067-9)

Uses:

•for the prevention of dry, hard stools

•for relief of occasional constipation

•this product generally produces a bowel movement within 12 to 72 hours.

Warnings and Precautions (34071-1)

Do not use

•if you are currently taking mineral oil, unless directed by a doctor

•when abdominal pain, nausea, or

vomiting are present

•for more than 1 week, unless directed by a doctor.

Section 34076-0 (34076-0)

Directions:

Adults and children 12 years of age and over:

take 1 softgel daily or as directed by a doctor.

Children under 12 years of age: take as directed by doctor.

Other Information:

each softgel contains: sodium 15 mg.

Store between 15-30 C (59-86 F)

Section 50569-3 (50569-3)

Ask a doctor before use if:

•you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if:

•you have rectal bleeding

•you fail to have a bowel movement after use. These could be signs of a serious condition.

Section 51727-6 (51727-6)

edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

•ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Section 55105-1 (55105-1)

Purpose

Stool Softener

Section 55106-9 (55106-9)

Active Ingredient (in each softgel)

Docusate Sodium 250 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:51.067633 · Updated: 2026-03-14T22:53:52.491278