FDA.reportPublic FDA data

Stool Softener

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-02-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:37

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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 15 mg store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

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 relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center 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 15 mg
  • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

Docusate Sodium

250 mg

Stool Softener

Laxative

Softgels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245468docusate sodium 250 MG Oral CapsulePSN2
1245468docusate sodium 250 MG Oral CapsuleSCD2
1245468DOSS Sodium 250 MG Oral CapsuleSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368071264364GTIN-13: 0368071264364
EAN-13: 0368071264364
GTIN-12: 368071264364
UPC-A: 368071264364
GTIN storage (14 digits): 00368071264364		68071-2643-6.jpg
Data codeData Matrix0100368071264364210000000002<GS>170000010000000<GS>68071-2643-6.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2643-62025-01-30C16284748780-12cef2736-5c56-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2643-6DOCUSATE SODIUM60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2643DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220308_d88e4a9c-bc3d-220f-e053-2a95a90a3a51.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6999-60EA - Each0904-6999fd084d32-1fa4-4246-a4b9-4ae829313b9512020-05-08
0904-6999-80EA - Each0904-699923352dc4-3f67-491a-a95d-5624167752bc12020-06-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-264368071-2643-6
0904-6999

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
MANNITOL3OWL53L36AIACT
SORBITAN6O92ICV9RUIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d89ebe50-03d7-b0f4-e053-2995a90a6119d88e4a9c-bc3d-220f-e053-2a95a90a3a512022-02-22WarningsExact identifier
spl id: d89ebe50-03d7-b0f4-e053-2995a90a6119
spl set id: d88e4a9c-bc3d-220f-e053-2a95a90a3a51

Reported adverse events (FAERS/openFDA)#

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