FDA.reportPublic FDA data

SENNA Syrup

Manufacturer
SDA Laboratories, Inc.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:54

Label at a glance#

ProductSENNA Syrup
Active ingredientSENNOSIDES A AND B
Label structure11 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally causes bowel movement in 6 to 12 hours

Dosage and administration

• shake well before use • take preferably at bedtime or as directed by a doctor Age Starting Dose Maximum dosage adults and children 12 years and older 2-3 teaspoonfuls once a day 3 teaspoonfuls twice a day 6 years to under 12 years of age 1-1½ teaspoonfuls once a day​ 1½ teaspoonfuls twice a day 2 to under 6 years of age 1/2-3/4 teaspoon once a day 3/4 teaspoon twice a day under 2 years of age ask a doctor ask a ...

Storage and handling

• Store at room temperature 15°-30°C (59°-86°F) TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 5 ml)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.8 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• generally causes bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you have

• stomach pain  • nausea  • vomiting

• notice a sudden change in bowel movement that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition

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.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before use
• take preferably at bedtime or as directed by a doctor

AgeStarting DoseMaximum dosage

adults and children

12 years and older

2-3 teaspoonfuls once a day3 teaspoonfuls twice a day

6 years to under

12 years of age

1-1½ teaspoonfuls once a day​

1½ teaspoonfuls twice

a day

2 to under 6 years

of age

1/2-3/4 teaspoon once a day3/4 teaspoon twice a day
under 2 years of ageask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

• Store at room temperature 15°-30°C (59°-86°F)

TAMPER EVIDENT:Do not use this product if breakaway band on cap is broken or missing

Inactive ingredient:

INACTIVE INGREDIENT SECTION

flavors, methyl paraben, propyl paraben, sucrose and water.

OTC - QUESTIONS SECTION

TO REPORT ADVERSE DRUG EVENTS CALL 800-687-0176

SPL UNCLASSIFIED SECTION

Natural Vegetable Laxative

For Gentle, Relief of Constipation

* Compare to Active ingredient of Senokot®

* This product is not manufactured or distributed by the owner of the registered trademark Senokot®

Distributed By: SDA Laboratories Inc.

280 Railroad Ave. Greenwich, CT. 06830

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SennasypSennasyp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN7
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD7
702311sennosides 8.8 MG per 5 mL Oral SyrupSY7
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY7
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66424-562-082021-03-15C16284748780-1ba0f9c33-1476-a910-e053-dadaa90a0b85SDA- Senna 562
66424-562-082021-01-29C16284748780-1ba0f9c33-1476-a910-e053-dadaa90a0b85SDA- Senna 562

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-562-08SENNA Syrup236 mL in 1 BOTTLE, PLASTICSYRUP2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-562SENNA SYRUP (SENNOSIDES A AND B) SYRUP [SDA LABORATORIES, INC.]7Current NDC, Legacy NDC, 1 package rows20241222_cfc6ab2f-5376-46fc-ac58-7dedd7010006.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-562-08ML - Milliliter66424-56252ad75f8-e737-4df9-b05c-3ca9cf29bbed12018-02-20

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66424-56266424-562-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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
SENNA SyrupSENNOSIDES A AND BSDA Laboratories, Inc.cfc6ab2f-5376-46fc-ac58-7dedd70100062024-12-20WarningsExact identifier
ndc (package): 66424-562-08
ndc (product): 66424-562
ndc11 (package): 66424056208
spl id: 29bbb628-c28a-9fbe-e063-6294a90a7a8b
spl set id: cfc6ab2f-5376-46fc-ac58-7dedd7010006

Reported adverse events (FAERS/openFDA)#

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