docusate sodium 100 mg

docusate sodium 100 mg
SPL v1
SPL
SPL Set ID 272c86f1-f229-2ebf-e063-6394a90a3471
Route
oral
Published
Effective Date 2024-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
gelatin, unspecified propylene glycol sorbitol fd&c red no. 40 water anhydrous citric acid polyethylene glycol, unspecified fd&c yellow no. 6 glycerin

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-11-30
Purpose

Stool softener laxative

Description

Drug Facts

Medication Information

Warnings

Purpose

Stool softener laxative

Directions
  • take with a glass of water -see Overdose warning

adults and children 12 years

of age and over

1 to 3 softgels daily. This dose may be taken as a single daily dose

or in divided doses
children 2 to under 12 years of age 1 softgel daily
children under 2 years of age ask a doctor

Other Information
  • each softgel contains: sodium 5mg
  • store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
  • contains FD&C Yellow No. 6
Inactive Ingredients

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible ink

Description

Drug Facts

Use
  • for relief of occasional constipation and irregularity.
  • This product generally produces bowel movement in 12 to 72 hours.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50570-1

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 51945-4

PuraVation Stool Softener

Docusate Sodium - 100 mg EACH

100 SOFTGELS

NDC 51013-819-01

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning

In case of overdose, get medical help or contact a Posion Control Center right away.

Questions Or Comments?

Call toll free: 1-855-215-8180

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.

Active Ingredient (in Each Softgel)

Docusate Sodium 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

Warnings

Purpose

Stool softener laxative

Directions
  • take with a glass of water -see Overdose warning

adults and children 12 years

of age and over

1 to 3 softgels daily. This dose may be taken as a single daily dose

or in divided doses
children 2 to under 12 years of age 1 softgel daily
children under 2 years of age ask a doctor

Other Information (Other information)
  • each softgel contains: sodium 5mg
  • store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
  • contains FD&C Yellow No. 6
Inactive Ingredients

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible ink

Use
  • for relief of occasional constipation and irregularity.
  • This product generally produces bowel movement in 12 to 72 hours.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Section 51945-4 (51945-4)

PuraVation Stool Softener

Docusate Sodium - 100 mg EACH

100 SOFTGELS

NDC 51013-819-01

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Posion Control Center right away.

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

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.

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

Docusate Sodium 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.838807 · Updated: 2026-03-14T23:05:23.931529