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Senna-S

SENNA-S DOCUSATE SODIUM 50 mg / STOOL SOFTENER SENNOSIDES 8.6 mg / LAXATIVE

Approved
Approval ID

f36c509e-b93b-4d7f-a18a-41e585369a15

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Granulation Technology, Inc.

DUNS: 847132193

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DOCUSATE SODIUM, SENNOSIDES

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63561-0187
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
DOCUSATE SODIUM, SENNOSIDES
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (14)

MICROCRYSTALLINE CELLULOSE 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
DOCUSATE SODIUMActive
Quantity: 50 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/29/2025

Principal Display Panel

NDC 63561-0187-01

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

100 Film-Coated Tablets

btl-label-sennaS-100s

![btl-label-sennaS-100s-peel](/dailymed/image.cfm?name=Senna- S_100_2.jpg&id=890134)

NDC 63561-0187-02

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

btl-label-sennaS-220s

![btl-label-sennaS-220s-peel](/dailymed/image.cfm?name=Senna- S_220_2.jpg&id=890134)

NDC 63561-0187-03

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

1000 Film-Coated Tablets

btl-label-sennaS-1000s

![btl-label-sennaS-1000s-peel](/dailymed/image.cfm?name=Senna- S_1000_2.jpg&id=890134)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/26/2024

Drug Facts

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/11/2025

Directions

  • 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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/11/2025

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/11/2025

Purpose

Stool softener

Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 11/26/2024

Warnings

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/11/2025

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 two weeks

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/11/2025

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/11/2025

Do not use

  • If you are now taking mineral oil, unless directed by a doctor
  • Laxative products for longer than one week unless directed by a doctor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/11/2025

Stop using 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

LOINC: 53414-9Updated: 6/11/2025

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/11/2025

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.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/29/2025

Other information

  • Each tablet contains:Calcium 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/11/2025

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 6/11/2025

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Senna-S - FDA Drug Approval Details