Senna Syrup

Manufacturer
Safecor Health, LLC | Llorens Pharmaceutical International Division, Inc.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:38

Label at a glance#

ProductSenna Syrup
Active ingredientSENNOSIDES
Label structure13 sections

Storage and handling

Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL = 1 teaspoonful)
Sennosides 8.8 mg

OTC - PURPOSE SECTION

Purpose
Laxative

INDICATIONS & USAGE SECTION

Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.

WARNINGS SECTION

WARNINGS: Do not use • laxative products for a period longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movement that continues over a period of 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have • rectal bleeding • no bowel movement after use of laxative

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

DOSAGE & ADMINISTRATION SECTION

1 teaspoonful = 5 mL
Directions:
  • Shake well before use
  • Do not exceed recommended dose
AgeStarting DoseMaximum Dosage
Adults and children 12 years of age and over2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
Children under 12 years of age Ask a doctorAsk a doctor

STORAGE AND HANDLING SECTION

Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                               Rev: 02/2020 PN5497

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

———Principal Display Panel———

SAFECOR HEALTH
                                                                              NDC: 48433-219-40
Senna Syrup                                                         Qty: 40
8.8 mg Sennosides per 5 mL                                 Lot: 20A0020

Contains 40 (5 mL) Unit Dose Cups                      Exp: 210203
See monograph for complete drug information.
Store at room temperature 15°C to 25°C (59°F to 77°F);
excursions between 26°C to 30°C (78°F to 86°F) are allowed.
Protect from excessive heat.
This package design is not child resistant. For institutional use only.
Shake well before use.
                                                                                     GTIN: 00348433219409
                                                                                     SN: 200600019

Pkg By: Safecor Health, LLC Columbus, OH 43204   Exp: 210203
     Questions or Comments: Call 1-800-447-1006       Lot: 20A0020

Box Label
Box Label
Unit Dose Cup Label
Unit Dose Cup 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-219-05Senna Syrup5 mL in 1 CUP, UNIT-DOSELIQUID54
48433-219-40Senna Syrup40 in 1 BOXLIQUID404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-219SENNA SYRUP (SENNOSIDES) LIQUID [SAFECOR HEALTH, LLC]4Current NDC, Legacy NDC, 2 package rows20250110_e1dca0d6-6e6e-4ba2-a7b8-009aeb00ef63.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-219-05ML - Milliliter48433-219725cd917-38dd-4450-8aab-82d5a0bae43312020-07-13
48433-219-40ML - Milliliter48433-21934a3e96a-c9e5-4f15-80c8-0d7ae17d74d912020-07-13
54859-808-08ML - Milliliter54859-808b7229fb6-73e6-4981-a025-f958cb6549ee12020-05-08

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
48433-21948433-219-05, 48433-219-40
54859-808

Ingredients#

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

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

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
Senna SyrupSENNOSIDESLlorens Pharmaceutical International Division, Inc.5be0163c-b7f7-46db-b738-78c2946a6cf62025-12-29WarningsExact identifier
ndc (product): 54859-808
Senna SyrupSENNOSIDESSafecor Health, LLCe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef632025-01-08WarningsExact identifier
ndc (package): 48433-219-40
ndc (package): 48433-219-05
ndc (product): 48433-219
ndc11 (package): 48433021905
ndc11 (package): 48433021940
spl id: 4faa6dd5-16b4-4d8e-8c93-ba05ba5b32f8
spl set id: e1dca0d6-6e6e-4ba2-a7b8-009aeb00ef63

Reported adverse events (FAERS/openFDA)#

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