FDA.reportPublic FDA data

Docusate Sodium, Sennosides

Manufacturer
CVS Pharmacy, Inc.
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:53

Label at a glance#

ProductDocusate Sodium, Sennosides
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

for overnight relief from occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours

Dosage and administration

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

    adults and children 12 years and older

    take 2-4 tablets daily

    children 6 to under 12 years of age

    take 1-2 tablets daily

    children 2 to under 6 years of age

    take up to 1 tablet daily

    children under 2

    ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 11 mg
  • each tablet contains: sodium 4 mg
  •  store at 25°C (77°F), protect from heat, light, and moisture

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-231-4670 Monday - Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30287

*This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® 2-IN-1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the active ingredients in Colace® 2-IN-1*

Stool Softener

DOCUSATE SODIUM 50 mg

SENNOSIDES 8.6 mg

Plus stimulant laxative

Convenient and predictable overnight relief of constipation

400 Tablets

3052C-label3052C-label

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-52069842-520-01, 69842-520-04, 69842-520-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
LIGHT MINERAL OILN6K5787QVPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BENZOATEOJ245FE5EUIACT
SENNOSIDES3FYP5M0IJXACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
HYPROMELLOSES3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
b4548030-7f10-d5b3-e053-2995a90a9b206dd61fee-5875-8d36-e053-2a91aa0afa692020-11-17WarningsExact identifier
spl id: b4548030-7f10-d5b3-e053-2995a90a9b20
spl set id: 6dd61fee-5875-8d36-e053-2a91aa0afa69

Reported adverse events (FAERS/openFDA)#

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