FDA.reportPublic FDA data

Senna Syrup

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:06:41

Label at a glance#

ProductSenna Syrup
Active ingredientSENNOSIDES
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Senna Syrup (8.8 mg/5 mL)

Active ingredient per 5 mL(1 Unit Dose) Sennosides 8.8 mg

OTC - PURPOSE SECTION

Drug Facts

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

PREGNANCY SECTION

If pregnant or breast-feeding, ask a healthcare 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 right away (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • shake well before use
  • do not exceed recommended dose
AgeStarting DoseMaximum Dose
Adults and children over 12 years of age10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor15 mL in the morning and 15 mL at bedtime
Children under 12 years of age Ask a doctorAsk a doctor

Other information

OTHER SAFETY INFORMATION

• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken

INACTIVE INGREDIENT SECTION

Inactive ingredients flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose.

OTC - QUESTIONS SECTION

Questions or comments? Call 1-844-474-7464

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

FG-38/Iss.: 04/2023

Lid Label

senna-lid-labelsenna-lid-label

Case Label

senna-case-labelsenna-case-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN4
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD4
702311sennosides 8.8 MG per 5 mL Oral SyrupSY4
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY4
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-310-05Senna Syrup5 mL in 1 CUP, UNIT-DOSELIQUID54
57237-310-54Senna Syrup40 in 1 BOXLIQUID404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-310-05ML - Milliliter57237-3106eb36316-ba9e-4db4-800d-52a693cd806512023-06-06
57237-310-54ML - Milliliter57237-310b9674635-807e-4376-a477-6368009531c312023-06-06

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
57237-31057237-310-05, 57237-310-54

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.802cc573-dee7-47ce-bf9a-0b2b886601d72025-07-01WarningsExact identifier
ndc (package): 57237-310-05
ndc (package): 57237-310-54
ndc (product): 57237-310
ndc11 (package): 57237031054
ndc11 (package): 57237031005
spl id: 33c438e4-9397-47a0-9ef4-6f2ffd89143c
spl set id: 802cc573-dee7-47ce-bf9a-0b2b886601d7

Reported adverse events (FAERS/openFDA)#

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