gc425 (426)

gc425 (426)
SPL v4
SPL
SPL Set ID b595063a-5fee-18c2-e053-2a95a90a5b99
Route
oral
Published
Effective Date 2013-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (250 mg)
Inactive Ingredients
gelatin glycerin food yellow 3 free acid water fd&c red no. 40 polyethylene glycol, unspecified sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-04-01
Purpose

Stool Softener

Description

Docusate Sodium 250 mg

Medication Information

Warnings

Ask a doctor before use if you

  • have stomach pain, nausea, or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement.

These could be signs of a serious condition.

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

use.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool Softener

Directions
  • adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
  • children under 12: do not use
  • do not exceed recommended dose

Other Information
  • each softgel contains: sodium 15 mg
  • store at 59°-77°F (15°-25°C)
  • keep tightly closed
  • product of Romania
  • Package not child resistant
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
Inactive Ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special

Description

Docusate Sodium 250 mg

Section 50565-1

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Package Label

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg

Structured Label Content

Warnings

Ask a doctor before use if you

  • have stomach pain, nausea, or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement.

These could be signs of a serious condition.

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

use.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool Softener

Directions
  • adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
  • children under 12: do not use
  • do not exceed recommended dose

Other Information (Other information)
  • each softgel contains: sodium 15 mg
  • store at 59°-77°F (15°-25°C)
  • keep tightly closed
  • product of Romania
  • Package not child resistant
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Package Label (package Label)

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Softgel) (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: 2026-02-15T12:02:21.494078 · Updated: 2026-03-14T23:01:51.692931