advanced rx - puregen - docusate sodium 250mg (80513-101)

advanced rx - puregen - docusate sodium 250mg (80513-101)
SPL v2
SPL
SPL Set ID fc8cf24e-8ca1-b3fb-e053-6294a90a7a50
Route
oral
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (250 mg)
Inactive Ingredients
propylene glycol 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: NV12 Shape: oval Color: red Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-05-25
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
  • Phenylketonurics: Contains phenylalanine 4 mg per softgel
  • store at 15°- 25°C (59°- 77°F)
Inactive Ingredients

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

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
  • Phenylketonurics: Contains phenylalanine 4 mg per softgel
  • store at 15°- 25°C (59°- 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

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

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:35.673374 · Updated: 2026-03-14T23:03:44.598062