DOCUSATE SODIUM

Manufacturer
DIRECTRX
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:26:25

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure12 sections

Storage and handling

each tablet contains 10 mg of calcium, sodium 5 mg store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

OTC - PURPOSE SECTION

Laxative

Stool Softner

OTC - PURPOSE SECTION

elieves occasional constipation (irregularity)
generally produces a bowel movement in 6-12 hours

WARNINGS SECTION

Do not use

laxative products for longer than 1 week unless directed by a doctor
if you are taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

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

INSTRUCTIONS FOR USE SECTION

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

Adults and children 12 years and over

2 tablets once a day

4 tablets twice a day

Children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

Children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

Children under 2 years

ask a doctor

ask a doctor

STORAGE AND HANDLING SECTION

each tablet contains 10 mg of calcium, sodium 5 mg
store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)

INACTIVE INGREDIENT SECTION


crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

OTC - QUESTIONS SECTION


866) 562-2756 Mon-Fri 8 AM to 4 PM EST

DOSAGE & ADMINISTRATION SECTION

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day

Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

INDICATIONS & USAGE SECTION

Uses:

Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

498-60498-60

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-498-60EA - Each61919-4982ac33aa0-04f2-4f75-90da-9f6d89470e1b12019-04-11
16103-378-11EA - Each16103-378011d0b12-3043-4597-a0fa-fbe72c961b7d12019-03-12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-49861919-498-60
16103-378

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
ndc (product): 16103-378
0711a7f4-47e4-1b64-e063-6394a90ab703861a97c1-c929-6139-e053-2991aa0a17f92023-10-06WarningsExact identifier
spl set id: 861a97c1-c929-6139-e053-2991aa0a17f9

Reported adverse events (FAERS/openFDA)#

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