Advanced Rx - PUREGEN - DOCUSATE SODIUM 250MG (80513-101)

Manufacturer
Advanced Rx LLC
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
weekly-update
Hydrated at
2026-07-17 21:43:42

Label at a glance#

ProductDOCUSATE SODIUM, EXTRA STRENGTH 250 MG
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and 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

Dosage and administration

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

Storage and handling

each softgel contains: sodium 20 mg Phenylketonurics: Contains phenylalanine 4 mg per softgel store at 15°- 25°C (59°- 77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH SOFTGEL)

OTC - ACTIVE INGREDIENT SECTION

DOCUSATE SODIUM 250 MG

PURPOSE

OTC - PURPOSE SECTION

Stool softener laxative

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 20 mg
  • Phenylketonurics: Contains phenylalanine 4 mg per softgel
  • store at 15°- 25°C (59°- 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-630-8895

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-10180513-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-09-13full-release2026-06-01 00:19:41

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
ndc (package): 80513-101-01
ndc (product): 80513-101
ndc11 (package): 80513010101
spl id: 55fe1154-f793-7cb6-e063-6294a90aad06
spl set id: fc8cf24e-8ca1-b3fb-e053-6294a90a7a50

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.