FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
Spirit Pharmaceuticals LLC | MEDGEL PRIVATE LIMITED
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:46:41

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure15 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

take with a glass of water Adults and children 12 years and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses Children 2 to under 12 years of age 1 softgel daily. Children under 2 years of age Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner laxative

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomittiong
  •  a sudden change in bowel habits that lasts more than 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if you

OTC - STOP USE SECTION

  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo need to use 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

Directions

DOSAGE & ADMINISTRATION SECTION

take with a glass of water

Adults and children 12 years and over

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 20-25°C  (68-77°F) 
  • protect from excessive humidity
  • do not use this product of the safety seal under the cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL- Valumeds Stool Softener 30 softels Bottle Labels-Single Tone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS TM

Compare to the active ingredient in

Dulcolax  ® Stool Softener  *

STOOL  SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief
Constipation Relief

30 SOFTGELS

Docusate sodium-Single ToneDocusate sodium-Single Tone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4
1115005docusate sodium 100 MG Oral CapsuleSCD4
1115005DOSS Sodium 100 MG Oral CapsuleSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-0317-32024-01-30C16284748780-11030e365-0aad-111a-e063-dadaa90a10e2VALUMEDS STOOL SOFTENER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0317-3DOCUSATE SODIUM1 in 1 CARTONCAPSULE, LIQUID FILLED14
68210-0317-3DOCUSATE SODIUM30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0317DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 2 package rows20220114_5ebc8cbc-b896-405f-8a23-14bcd0a70353.zip

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
68210-031768210-0317-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
d57c80e1-84df-5986-e053-2a95a90a0b605ebc8cbc-b896-405f-8a23-14bcd0a703532022-01-13WarningsExact identifier
spl id: d57c80e1-84df-5986-e053-2a95a90a0b60
spl set id: 5ebc8cbc-b896-405f-8a23-14bcd0a70353

Reported adverse events (FAERS/openFDA)#

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