Stool Softener

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:39:44

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Dosage and administration

take with a glass of water -see Overdose warning adults and children 12 years of age 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

Storage and handling

each softgel contains: sodium 5mg store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity contains FD&C Yellow No. 6

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 softener laxative

Use

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation and irregularity.
  • This product generally produces bowel movement in 12 to 72 hours.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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 or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water -see Overdose warning

adults and children 12 years

of age 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 age1 softgel daily
children under 2 years of ageask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 5mg
  • store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
  • contains FD&C Yellow No. 6

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PC09-00 DSS 100mg-100ct.jpgPC09-00 DSS 100mg-100ct.jpgPuraVation Stool Softener

Docusate Sodium - 100 mg EACH

100 SOFTGELS

NDC 51013-819-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN1
1115005docusate sodium 100 MG Oral CapsuleSCD1
1115005DOSS Sodium 100 MG Oral CapsuleSY1

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-819-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-819STOOL SOFTENER (DOCUSATE SODIUM 100MG) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Current NDC, 1 package rows20241130_272c86f1-f229-2ebf-e063-6394a90a3471.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
51013-81951013-819-01

Ingredients#

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

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

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
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
ndc (package): 51013-819-01
ndc (product): 51013-819
ndc11 (package): 51013081901
spl id: 272c86f1-f22a-2ebf-e063-6394a90a3471
spl set id: 272c86f1-f229-2ebf-e063-6394a90a3471

Reported adverse events (FAERS/openFDA)#

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