FDA.reportPublic FDA data

Sennosides and Docusate Sodium

Manufacturer
American Health Packaging
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:10:06

Label at a glance#

ProductSennosides and Docusate Sodium
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours

Dosage and administration

do not exceed 8 tablets in 24 hours Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime Children under 12 years ask a doctor

Storage and handling

each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium. store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

  • 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 or vomiting
  • noticed a sudden change in bowel habits that lasts over two 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

  • do not exceed 8 tablets in 24 hours
  • Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
  • Children under 12 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium.
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F).
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

SPL UNCLASSIFIED SECTION

The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

Distributed by:
American Health Packaging, Columbus, Ohio 43217         Product of India

762201
0462201/0825

Package/Label Display Panel – Carton – 8.6 mg/50 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8.6 mg 50mg Sennosides DSS Tablets Carton8.6 mg 50mg Sennosides DSS Tablets Carton

NDC 60687- 622-01

Sennosides and Docusate Sodium Tablets
Natural Vegetable Laxative with Stool Softener

8.6 mg/50 mg

100 Tablets (10 x 10)

Drug Facts
Active ingredients (in each tablet)......................................................................Purpose
Docusate Sodium 50 mg...............................................................................Stool softener
Sennosides 8.6 mg............................................................................................... Laxative

The drug product contained in this package is from
NDC # 57896-555, Geri-Care Pharmaceuticals Corp.         Product of India

Distributed by:
American Health Packaging, Columbus, Ohio 43217

762201
0462201/0825

Package/Label Display Panel – Blister – 8.6 mg/50 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8.6 mg/50 mg Sennosides and Docusate Sodium Tablet Blister8.6 mg/50 mg Sennosides and Docusate Sodium Tablet Blister

Sennosides and Docusate
Sodium Tablet
Laxative/Stool Softener

8.6 mg/50 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-622-01Sennosides and Docusate Sodium100 in 1 BOX, UNIT-DOSETABLET1004
60687-622-11Sennosides and Docusate Sodium1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-622-11EA - Each60687-6228fc84181-fe36-4498-9701-a6b94311bbe012021-08-05
57896-555-01EA - Each57896-55599ff87f3-bd78-44e5-95d2-ced09a47e88712020-08-06
57896-555-06EA - Each57896-555c097fdf8-843e-480e-b2c8-169d6169722112021-12-08
57896-555-10EA - Each57896-555a8f7f135-b3ac-4250-967e-cb39c37b340612020-06-05
57896-555-20EA - Each57896-5552bd72b42-9f99-4221-abc0-be95352cf75212022-03-09

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60687-62260687-622-11, 60687-622-01
57896-555

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
ndc (package): 60687-622-01
ndc (package): 60687-622-11
ndc (product): 60687-622
ndc11 (package): 60687062211
ndc11 (package): 60687062201
spl id: 3c2f58eb-5f46-5945-e063-6294a90a40c0
spl set id: 4b84d5d7-43cf-47bb-af59-088550c3a0bc
SENNA-PLUSSENNOSIDES AND DOCUSATE SODIUMGeri-Care Pharmaceutical Corp8a0882ed-f623-2359-e053-2995a90a6f982024-11-28WarningsExact identifier
ndc (product): 57896-555

Reported adverse events (FAERS/openFDA)#

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