FDA.reportPublic FDA data

Senna Syrup

Manufacturer
Patrin Pharma, Inc.
Effective date
2024-05-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:14

Label at a glance#

ProductSenna
Active ingredientSennosides
Label structure14 sections

Indications and uses

Relieves occasional constipation (irregularity) Generally causes bowel movement in 6 to 12 hours

Dosage and administration

Shake well before using. Do not exceed maximum dose. Take at bedtime or as directed by a doctor. AGE USUAL DOSE MAXIMUM DOSAGE Adults and children 12 years and older 2-3 teaspoons (10 to 15 mL) once a day 3 teaspoons (15 mL) twice a day 6 to 12 years 1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day 1 1/2 teaspoons (7.5 mL) twice a day 2 to 6 years 1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day 3/4 teaspoon (3.75 mL...

Storage and handling

Store at controlled room temperature 20-25°C (68-77°F). Excursions permitted 15-30°C (59-86°F). Tamper-Evident: Do not use if foil seal over cup is torn or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have stomach pain, nausea or vomiting
  • notice a change in bowel habits that last over two weeks
  • are pregnant or breast feeding

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after 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 using. Do not exceed maximum dose.

Take at bedtime or as directed by a doctor.

AGEUSUAL DOSEMAXIMUM DOSAGE
Adults and children 12 years and older2-3 teaspoons (10 to 15 mL) once a day3 teaspoons (15 mL) twice a day
6 to 12 years1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day1 1/2 teaspoons (7.5 mL) twice a day
2 to 6 years1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day3/4 teaspoon (3.75 mL) once a day
under 2 years of ageConsult a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20-25°C (68-77°F).

Excursions permitted 15-30°C (59-86°F).

Tamper-Evident: Do not use if foil seal over cup is torn or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose

Questions Or Comments?

OTC - QUESTIONS SECTION

Call (800) 936 3088. You may also report serious side effects to this phone number.

How Supplied

HOW SUPPLIED SECTION

  • A chocolate flavored syrup supplied in the following oral dosage cup:
NDC 39328-120-05:
NDC 39328-120-50:		5 mL unit dose cup
Case contains 50 unit dose cups of 5 mL
NDC 39328-220-15:
NDC 39328-220-50:		15 mL unit dose cup
Case contains 50 unit dose cups of 15 mL

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 39328-020-08

Senna Syrup
Natural Vegetable
Laxative

8.8mg/5 mL

Alcohol Free • Dye Free

8 fl. oz (237 mL)

PATRIN
PHARMA

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 39328-120-05

Senna Syrup

8.8 mg/5 mL

Shake Well

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0124

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 15 mL

NDC 39328-220-15

Senna Syrup

26.4 mg/15 mL

Shake Well

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: mm/dd/yyyy

Patrin Pharma

Skokie, IL 60076

Rev 02.0823

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label
PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN1
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD1
702311sennosides 8.8 MG per 5 mL Oral SyrupSY1
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY1
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-020-08Senna237 mL in 1 BOTTLE, PLASTICSYRUP2371
39328-120-05Senna UD5 mL in 1 CUP, UNIT-DOSESYRUP51
39328-120-50Senna UD10 in 1 TRAYSYRUP101
39328-120-50Senna UD5 in 1 CASESYRUP51
39328-120-99Senna UD10 in 1 CASESYRUP101
39328-120-99Senna UD10 in 1 TRAYSYRUP101
39328-220-15Senna UD15 mL in 1 CUP, UNIT-DOSESYRUP151
39328-220-50Senna UD5 in 1 CASESYRUP51
39328-220-50Senna UD10 in 1 TRAYSYRUP101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-020SENNA (SENNOSIDES) SYRUP SENNA UD (SENNOSIDES) SYRUP [PATRIN PHARMA, INC.]1Current NDC, 1 package rows20240601_a9f1ef8d-8700-481f-a709-972bb9d27153.zip
39328-120SENNA (SENNOSIDES) SYRUP SENNA UD (SENNOSIDES) SYRUP [PATRIN PHARMA, INC.]1Current NDC, 5 package rows20240601_a9f1ef8d-8700-481f-a709-972bb9d27153.zip
39328-220SENNA (SENNOSIDES) SYRUP SENNA UD (SENNOSIDES) SYRUP [PATRIN PHARMA, INC.]1Current NDC, 3 package rows20240601_a9f1ef8d-8700-481f-a709-972bb9d27153.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-020-08ML - Milliliter39328-0207e9020a9-1be1-40a0-9c40-5f773f4a182d12024-06-10
39328-120-05ML - Milliliter39328-12092d5601a-b44b-4536-b278-e9ec4a394d6412024-06-10
39328-120-50ML - Milliliter39328-120b3c72434-6109-4b98-8bfc-35adaf2a847912024-06-10
39328-220-15ML - Milliliter39328-220b83588e6-2a65-482b-bd99-d143802aafa712024-06-10
39328-220-50ML - Milliliter39328-2202a5ce532-07a4-4c72-9cc0-7154296527be12024-06-10

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
39328-02039328-020-08
39328-12039328-120-05, 39328-120-50, 39328-120-99
39328-22039328-220-15, 39328-220-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sennosides3FYP5M0IJXACTIB
methylparabenA2I8C7HI9TIACT
propylene glycol6DC9Q167V3IACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
sucroseC151H8M554IACT
Sennosides3FYP5M0IJXACTIB
methylparabenA2I8C7HI9TIACT
propylene glycol6DC9Q167V3IACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
sucroseC151H8M554IACT
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
SennaSENNOSIDESPatrin Pharma, Inc.a9f1ef8d-8700-481f-a709-972bb9d271532024-05-30WarningsExact identifier
ndc (package): 39328-220-50
ndc (package): 39328-220-15
ndc (package): 39328-020-08
ndc (package): 39328-120-05
ndc (package): 39328-120-50
ndc (package): 39328-120-99
ndc (product): 39328-120
ndc (product): 39328-220
ndc (product): 39328-020
ndc11 (package): 39328002008
ndc11 (package): 39328012005
ndc11 (package): 39328012099
ndc11 (package): 39328022050
ndc11 (package): 39328012050
ndc11 (package): 39328022015
spl id: b42865b6-223b-461b-aabd-ca548a0339fa
spl set id: a9f1ef8d-8700-481f-a709-972bb9d27153

Reported adverse events (FAERS/openFDA)#

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