DOCUSATE SODIUM

Manufacturer
DirectRx
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:11:36

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool softener laxative

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

OTC - WHEN USING SECTION

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

WARNINGS 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

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 laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

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.

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE SECTION

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

OTC - QUESTIONS SECTION

Call 1-800-616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-236-30EA - Each72189-23603548c0a-3aea-468a-8115-5905f30483e212021-10-08
0904-6998-60EA - Each0904-6998d821c784-9742-4476-8dfb-c2f1c92a60eb12021-03-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-23672189-236-30
0904-6998

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
07d9d78a-eff2-2e43-e063-6294a90ace12cbf97460-ea46-cf62-e053-2a95a90a3a992023-10-16WarningsExact identifier
spl set id: cbf97460-ea46-cf62-e053-2a95a90a3a99

Reported adverse events (FAERS/openFDA)#

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