FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Major Pharmaceuticals | LNK International, Inc.
Effective date
2023-05-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:11

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed take with a glass of water 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 capsules daily children 2 to under 12 years take 1 capsule daily   children under 2 years ask a doctor

Storage and handling

each capsule contains:  sodium 8 mg Very Low Sodium store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from light, heat and moisture TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking mineral oil.

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 laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take with a glass of water
  • 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 capsules daily
children 2 to under 12
years		take 1 capsule daily  
children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: sodium 8 mg
    Very Low Sodium
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from light, heat and moisture
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

OTC - QUESTIONS SECTION

 (800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7115-61

Unit Dose

Docusate Sodium
Stool Softener Laxative
100 mg

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

100 Softgels

50844     ORG112075212

Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152

Product of Dubai
Packaged and Quality Assured in the USA

Rev. 02/21   M-17   Re-order No. 701287

Major 44-752
Major 44-752

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7115-61EA - Each0904-711513c8fa70-0045-4950-a8b5-337e543a208a12021-07-15

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-71150904-7115-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LIGHT MINERAL OILN6K5787QVPIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
00bf0cec-41b6-4e32-b2cc-e9f9092ec4d54419de58-79bf-4ab7-93e5-5eea8603839b2023-05-18WarningsExact identifier
spl id: 00bf0cec-41b6-4e32-b2cc-e9f9092ec4d5
spl set id: 4419de58-79bf-4ab7-93e5-5eea8603839b

Reported adverse events (FAERS/openFDA)#

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