FDA.reportPublic FDA data

Senna S

Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:56

Label at a glance#

ProductSenna S
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 or older 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 20 mg each tablet contains: sodium 6 mg 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 lasts over 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
 age starting dosage maximum dosage 
adults and children 12 years of age or older2 tablets once a day4 tablets twice a day 
children 6 to under 12 years1 tablet once a day2 tablets twice a day 
children 2 to under 6 years1/2 tablet once a day 1 tablet twice a day 
children under 2 yearsask a doctor ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc*,  titanium dioxide

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®  

Natural laxative 

Laxative + Stool Softener

Docusate sodium 50 mg

Stool Softener

Sennosides 8.6 mg

Laxative

Gentle, overnight relief of constipation

Tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

†This product is not manufactured or distributed by Purdue Products L.P., distributor Senokot-S®.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural Vegetable Laxative + Stool Softener
Natural Vegetable Laxative + Stool Softener

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0485-12023-02-09C16284748780-1f386c64a-3606-0266-e053-dadaa90a7c1aDrug Facts
63548-0485-12023-01-30C16284748780-1f386c64a-3606-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63548-048563548-0485-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
b1c22f92-a44f-4e9e-9523-326874c91bebe99a9bbb-3692-49eb-a482-72c851a43fae2023-02-09WarningsExact identifier
spl id: b1c22f92-a44f-4e9e-9523-326874c91beb
spl set id: e99a9bbb-3692-49eb-a482-72c851a43fae

Reported adverse events (FAERS/openFDA)#

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