FDA.reportPublic FDA data

DOCUSATE SODIUM 50MG SOFTGEL (RED)

Manufacturer
CVS Pharmacy | TIME CAP LABORATORIES, INC | MARKSANS PHARMA LIMITED
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:41

Label at a glance#

ProductDOCUSATE SODIUM 50MG SOFTGEL (RED)
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Docusate sodium USP 50 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

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 stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses

adults and children

12 years and over 		take 1-6 softgels daily

children 2 to

under 12 years of age 		take 1-3 softgels daily
children under 2 years ask a doctor

OTHER SAFETY INFORMATION

Other information

  • each softgel contains: sodium 3 mg VERY LOW SODIUM
  • Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C red 33, FD&C blue 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

651T_100ct_IFC651T_100ct_IFC

651T_100ct_LBL651T_100ct_LBL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247759docusate sodium 50 MG Oral CapsulePSN2
1247759docusate sodium 50 MG Oral CapsuleSCD2
1247759DOSS Sodium 50 MG Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-651-01DOCUSATE SODIUM 50MG SOFTGEL (RED)100 in 1 BOTTLECAPSULE, LIQUID FILLED1002
51316-651-01DOCUSATE SODIUM 50MG SOFTGEL (RED)1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-651DOCUSATE SODIUM 50MG SOFTGEL (RED) (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY]2Current NDC, 2 package rows20250308_273e5b52-1cf9-2525-e063-6394a90a8b4f.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-65151316-651-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
NONCRYSTALLIZING SORBITOL SOLUTION9E0S3UM200IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SHELLAC46N107B71OIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
ndc (package): 51316-651-01
ndc (product): 51316-651
ndc11 (package): 51316065101
spl id: 2d4cf80d-b3d4-716d-e063-6394a90acd43
spl set id: 273e5b52-1cf9-2525-e063-6394a90a8b4f

Reported adverse events (FAERS/openFDA)#

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