DOCUSATE SODIUM 100MG

Manufacturer
SHANDONG ROSEMED BIOOHARM LLC
Effective date
2024-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:47

Label at a glance#

ProductDOCUSATE SODIUM 100MG
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 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 and under 12 years of age 1 softgel daily children under 2 years of age ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each s oftgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

USE IN SPECIFIC POPULATIONS SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

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

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

Stop use and ask a doctor if

  • 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

If pregnant or breast-feeding, ask a health professional before use.

Directions

INSTRUCTIONS FOR USE SECTION

take with a glass of water

adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 and under 12 years of age1 softgel daily
children under 2 years of ageask a doctor

Other information

INSTRUCTIONS FOR USE SECTION

  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Dosage & administraton

DOSAGE & ADMINISTRATION SECTION

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Indications & usage section

adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 and under 12 years of age1 softgel daily
children under 2 years of ageask a doctor

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Label Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules
NDC. No : 84328-001

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

11

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84328-001-012025-07-29C16284748780-13b156c62-2b9e-fb37-e063-e6dba90a4e07188d20f5-43de-d52a-e063-6394a90a451a
84328-001-022025-07-29C16284748780-13b156c62-2b9e-fb37-e063-e6dba90a4e07188d20f5-43de-d52a-e063-6394a90a451a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84328-001-01DOCUSATE SODIUM 100MG1 in 1 BOXCAPSULE, LIQUID FILLED12
84328-001-01DOCUSATE SODIUM 100MG20000 in 1 BAGCAPSULE, LIQUID FILLED200002
84328-001-02DOCUSATE SODIUM 100MG1 in 1 BOXCAPSULE, LIQUID FILLED12
84328-001-02DOCUSATE SODIUM 100MG15000 in 1 BAGCAPSULE, LIQUID FILLED150002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84328-001DOCUSATE SODIUM 100MG (DOCUSATE SODIUM 100MG- DOCUSATE SODIUM CAPSULE, LIQUID FILLED) CAPSULE, LIQUID FILLED [SHANDONG ROSEMED BIOOHARM LLC]24 package rows20240827_188d20f5-43de-d52a-e063-6394a90a451a.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
84328-00184328-001-01, 84328-001-02

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
2091a352-e44b-2bba-e063-6294a90a00f8188d20f5-43de-d52a-e063-6394a90a451a2024-08-26WarningsExact identifier
spl id: 2091a352-e44b-2bba-e063-6294a90a00f8
spl set id: 188d20f5-43de-d52a-e063-6394a90a451a

Reported adverse events (FAERS/openFDA)#

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