FDA.reportPublic FDA data

CVS 652T DOCUSATE SODIUM 50MG SOFTGEL(Dye-free)

Manufacturer
CVS Pharmacy | Time Cap Laboratories, Inc. | MARKSANS PHARMA LIMITED
Effective date
2026-08-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-08 02:01:23

Label at a glance#

ProductDocusate Sodium softgels 50mg (Dye Free)
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 ferrosoferric oxide, gelatin, glycerin, polyethylene glycol, propylene glycol, noncrystallizing sorbitol solution, purified water, shellac

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

652T Docusate Sodium Softgels, 28ct label

652T 28ct label652T 28ct label

652T Docusate Sodium Softgels, 28ct Carton

652T 28ct carton652T 28ct carton

652T Docusate Sodium Softgels, 30ct Label

652T CVS 30ct label652T CVS 30ct label

652T Docusate Sodium Softgels, 30ct Carton

652T CVS 30ct carton652T CVS 30ct carton

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
51316-65251316-652-03, 51316-652-82

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
NONCRYSTALLIZING SORBITOL SOLUTION9E0S3UM200IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
GELATIN2G86QN327LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-07-14daily-update2026-07-18 05:10:24
42026-06-19monthly-update2026-07-17 21:35:00
32026-06-08daily-update2026-06-12 05:10:10
22025-02-04full-release2026-06-01 00:56:42

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 softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
ndc (package): 51316-652-82
ndc (package): 51316-652-03
ndc (product): 51316-652
ndc11 (package): 51316065282
ndc11 (package): 51316065203
spl id: 584927ea-eb1e-f364-e063-6294a90a9d87
spl set id: 273ea95f-3c9c-98e8-e063-6294a90a2135

Reported adverse events (FAERS/openFDA)#

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