FDA.reportPublic FDA data

gc425 (426)

Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:31

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368071529760GTIN-13: 0368071529760
EAN-13: 0368071529760
GTIN-12: 368071529760
UPC-A: 368071529760
GTIN storage (14 digits): 00368071529760		68071-5297-6.jpg
Data codeData Matrix0100368071529760210000000002<GS>170000010000000<GS>68071-5297-6.jpg

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
68071-529768071-5297-6
57896-426

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.53727f3a-914c-0e2c-e063-6394a90a38862026-06-04WarningsExact identifier
ndc (package): 68071-5297-6
ndc (product): 68071-5297
ndc11 (package): 68071529706
spl id: 53728778-9acd-ab94-e063-6294a90a47ec
spl set id: 53727f3a-914c-0e2c-e063-6394a90a3886
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
ndc (product): 57896-426

Reported adverse events (FAERS/openFDA)#

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