Docusate sodium

Manufacturer
APNAR PHARMA LP | APNAR PHARMA LLP
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:44

Label at a glance#

ProductDocusate sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Storage and handling

Other Information each softgel contains: sodium 5 mg store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (In each softgel)

Docusate Sodium.... 100 mg

OTC - PURPOSE SECTION

Purpose

Stool softener laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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

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

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 a signs of a serious condition.
  • you need to use a stool softner laxative for more than 1 week

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 (1-800-222-1222) right away.

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

STORAGE AND HANDLING SECTION

Other Information

each softgel contains: sodium 5 mg
store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

INACTIVE INGREDIENT SECTION

Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink

OTC - QUESTIONS SECTION

Questions or Comments ?

Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Colace® Regular Strength Stool Softener†

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

Rev.: 03/2023

Manufactured by:
Apnar Pharma LLP
East Windsor, NJ 08520

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24689-130-01

Docusate Sodium 100mg

Stool Softener Laxative

MADE IN USA

100 Softgels

Docusate Sodium Softgel lable-100mgDocusate Sodium Softgel lable-100mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
24689-130-01Docusate sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-130DOCUSATE SODIUM CAPSULE, LIQUID FILLED [APNAR PHARMA LP]2Current NDC, 1 package rows20250112_05b0732b-012f-78ee-e063-6294a90a839a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-130-01EA - Each24689-13084cac624-790b-4dbf-a93f-25a39727a8d912023-12-05

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-13024689-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
ndc (package): 24689-130-01
ndc (product): 24689-130
ndc11 (package): 24689013001
spl id: 2b4a8b5e-8724-3c78-e063-6394a90a194d
spl set id: 05b0732b-012f-78ee-e063-6294a90a839a

Reported adverse events (FAERS/openFDA)#

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