FDA.reportPublic FDA data

Laxative Stool Softener

Manufacturer
CVS Pharmacy
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:39:57

Label at a glance#

ProductLaxative Stool Softener
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor  age starting dosage  maximum dosage  adults and children 12 years of age 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

each tablet contains : calcium 30 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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 may indicate a serious condition.

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

  • take preferably at bedtime or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate*, stearic acid, talc*,  titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Senokot-S®†

Senna Plus 

DOCUSATE SODIUM, 50 mg

SENNOSIDES, 8.6 mg

Laxative/Stool softener

Natural vegetable laxative ingredient plus stool softener

TABLETS

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

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-830-182020-10-27C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-302020-10-27C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-182020-09-27C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-302020-09-27C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-182020-09-25C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-302020-09-25C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-182020-07-22C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts
69842-830-302020-07-22C16284748780-1ab0e2407-32bc-f274-e053-dbdaa90a6471Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-83069842-830-30, 69842-830-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM OXIDELMI26O6933IACT

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
c1552c5d-2e53-4348-a7f5-4bee56b8e31741d7d91f-b580-4e26-939e-ec4734b0779a2023-01-18WarningsExact identifier
spl id: c1552c5d-2e53-4348-a7f5-4bee56b8e317
spl set id: 41d7d91f-b580-4e26-939e-ec4734b0779a

Reported adverse events (FAERS/openFDA)#

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