FDA.reportPublic FDA data

STOOL SOFTENER DOCUSATE SODIUM 50mg, Capsule, liquid filled

Manufacturer
CVS PHARMACY, INC. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:35

Label at a glance#

ProductSTOOL SOFTENER DOCUSATE SODIUM 50 MG
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

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 to 6 softgels daily Children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor

Storage and handling

each softgel contains: sodium 3 mg VERY LOW SODIUM store at 15°-30°C (59°-86°F) Keep tightly closed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 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

Do not use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless told to do so 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 lasts 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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 to 6 softgels daily

Children 2 to under 12 years of age

take 1 to 3 softgels daily

children under 2 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 3 mg
    VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F)

    Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China

PRINCIPAL DISPLAY PANEL - 30ct Carton and Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STOOL SOFTENER DOCUSATE SODIUM 50 MG 30ct

NDC 69842-072-20

Compare to the active ingredient in Colace® 50 mg

30ct Carton Label30ct Carton Label

30ct Bottle Label30ct Bottle Label

PRINCIPAL DISPLAY PANEL - 100ct Carton and Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STOOL SOFTENER DOCUSATE SODIUM 50 MG 100ct

NDC 69842-072-24

Compare to the active ingredient in Colace® 50 mg

100ct Carton Label100ct Carton Label

100ct Bottle Label100ct Bottle Label

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-072-202025-01-30C16284748780-12cef2736-6a49-d83d-e063-dadaa90ab31fSTOOL SOFTENER DOCUSATE SODIUM 50mg, Capsule, liquid filled
69842-072-242025-01-30C16284748780-12cef2736-6a49-d83d-e063-dadaa90ab31fSTOOL SOFTENER DOCUSATE SODIUM 50mg, Capsule, liquid filled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-072-20STOOL SOFTENER DOCUSATE SODIUM 50 MG1 in 1 CARTONCAPSULE, LIQUID FILLED12
69842-072-20STOOL SOFTENER DOCUSATE SODIUM 50 MG30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED302
69842-072-24STOOL SOFTENER DOCUSATE SODIUM 50 MG1 in 1 CARTONCAPSULE, LIQUID FILLED12
69842-072-24STOOL SOFTENER DOCUSATE SODIUM 50 MG100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-072STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]2Legacy NDC, 4 package rows20191122_3f6c1ef9-e286-416f-b727-7be08bef49fa.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-07269842-072-20, 69842-072-24

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
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
95861d39-f88d-4c68-aa90-3fc440be8a803f6c1ef9-e286-416f-b727-7be08bef49fa2019-11-21WarningsExact identifier
spl id: 95861d39-f88d-4c68-aa90-3fc440be8a80
spl set id: 3f6c1ef9-e286-416f-b727-7be08bef49fa

Reported adverse events (FAERS/openFDA)#

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