FDA.reportPublic FDA data

Senna Syrup

Manufacturer
Rising Pharma Holdings, Inc. | Invahealth Inc.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:34

Label at a glance#

ProductSenna Syrup
Active ingredientSENNOSIDES
Label structure11 sections

Storage and handling

Other information store at room temperature 15° to 25° C (59° to 77° F) TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Senna Syrup

Active ingredient

(in each 5 mL teaspoonful)

Sennosides - 8.8 mg

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

Do not use laxative products for longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • noticed a change in bowel habits that lasts over two weeks.

Stope 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.

PREGNANCY SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • shake well before using
  • Do not exceed recommended dose
AgeStarting DoseMaximum Dose
 adults and children 12 years and older 2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime
Under 12 years of age ask a doctor ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 15° to 25° C (59° to 77° F)

TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients:artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose.

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-844-474-7464

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sennalabel01sennalabel01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN2
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD2
702311sennosides 8.8 MG per 5 mL Oral SyrupSY2
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY2
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-301-24Senna Syrup237 mL in 1 BOTTLELIQUID2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-301SENNA SYRUP (SENNOSIDES) LIQUID [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 1 package rows20241020_dc636b83-6eca-412e-bac5-0c736b371ca7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-301-24ML - Milliliter57237-3019c39a687-d4e6-4156-94ae-a859b4cda45b12022-10-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-30157237-301-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT

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 SyrupSENNOSIDESRising Pharma Holdings, Inc.dc636b83-6eca-412e-bac5-0c736b371ca72024-10-18WarningsExact identifier
ndc (package): 57237-301-24
ndc (product): 57237-301
ndc11 (package): 57237030124
spl id: 72024c96-34c8-40af-b26a-147f0e7d4f0a
spl set id: dc636b83-6eca-412e-bac5-0c736b371ca7

Reported adverse events (FAERS/openFDA)#

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