advanced rx - puregen - docusate sodium 250mg (80513-100)

advanced rx - puregen - docusate sodium 250mg (80513-100)
SPL v4
SPL
SPL Set ID e8be12c5-c591-eadd-e053-2a95a90a431b
Route
oral
Published
Effective Date 2022-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (250 mg)
Inactive Ingredients
fd&c yellow no. 6 fd&c red no. 40 glycerin gelatin type b bovine (160 bloom) polyethylene glycol, unspecified water sorbitol solution

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-09-15
Purpose

Stool softener laxative

Description

DOCUSATE SODIUM 250 MG

Medication Information

Warnings

Do not use if you are presently taking mineral oil, unless directed by a doctor.



Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.

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
Purpose

Stool softener laxative

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: ask a doctor
Other Information
  • each softgel contains: sodium 20 mg
  • store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.

Description

DOCUSATE SODIUM 250 MG

Questions?

call 1-800-630-8895

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4

Active Ingredient (in Each Softgel)

DOCUSATE SODIUM 250 MG

Structured Label Content

Warnings (WARNINGS)

Do not use if you are presently taking mineral oil, unless directed by a doctor.



Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.

Uses (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
Purpose (PURPOSE)

Stool softener laxative

Directions (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: ask a doctor
Other Information (OTHER INFORMATION)
  • each softgel contains: sodium 20 mg
  • store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.

Questions? (QUESTIONS?)

call 1-800-630-8895

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4 (51945-4)

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: 2026-02-15T12:03:35.370106 · Updated: 2026-03-14T23:03:44.598062