FDA.reportPublic FDA data

Senna Syrup

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:58

Label at a glance#

ProductSENNA
Active ingredientSENNOSIDES
Label structure13 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement is 6-12 hours

Dosage and administration

Take preferably at bedtime​ or as directed by a doctor. Shake well before using. Do not exceed recommended dose.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH 5mL TEASPOONFUL)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.8 mg

PURPOSE

OTC - PURPOSE SECTION

Laxative

USES

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement is 6-12 hours

Do Not Use

OTC - DO NOT USE SECTION

  • longer than 1 week unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present

Ask a doctor before use

WARNINGS SECTION

Ask a doctor before use if you have noticed a sudden change in bowel movements that continues over a period of 2 weeks

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drgus. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Take preferably at bedtime​ or as directed by a doctor. Shake well before using. Do not exceed recommended dose.

Dosage ChartDosage Chart

Other Information

SPL UNCLASSIFIED SECTION

  • avoid excessive heat
  • store at room temperature 15°-25°C (59°-86°F).
  • Tamper-evident: do not use if aluminum foil seal over bottle opening is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-069-58

Reliable-1®

Senna Syrup

Natural Vegetable Laxative

For Gentle Relief of Constipation

Alcohol Free

Natural Chocolate Flavor

8 fl. oz. (237 ml)

Senna LabelSenna Label

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580

www.reliable1labs.com

516-341-0666 Mon-Fri 8:30am-4:30pm

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-069-582023-01-30C16284748780-1f386c64a-0745-0266-e053-dadaa90a7c1aSenna Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-069-58SENNA237 mL in 1 BOTTLE, PLASTICSYRUP2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-069SENNA (SENNOSIDES) SYRUP [RELIABLE 1 LABORATORIES LLC]4Current NDC, Legacy NDC, 1 package rows20250213_c8aa7ae9-7d00-db7d-e053-2995a90ae72b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-069-58ML - Milliliter69618-069576c7147-81a3-4d0f-8e74-5a33f9b1e2c812021-09-07

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
69618-06969618-069-58

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
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SENNOSIDES3FYP5M0IJXACTIB
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
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
ndc (package): 69618-069-58
ndc (product): 69618-069
ndc11 (package): 69618006958
spl id: 2de53996-629d-7455-e063-6294a90a21e4
spl set id: c8aa7ae9-7d00-db7d-e053-2995a90ae72b

Reported adverse events (FAERS/openFDA)#

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