FDA.reportPublic FDA data

Melatonin Tablets 3 mg

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2020-08-30
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:42

Label at a glance#

ProductSafrel Melatonin
Active ingredientMelatonin
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

SUPPLEMENT FACTS
Suggested Use: For adults, chew two gummies 30 minutes prior to sleep event. Gummy should be chewed before swallowing.
Serving Size: 2 gummiesServings Per Container: 30
Amount per serving%Daily Value
Melatonin         3mg**
** Daily Value (DV) not established

Other ingredients: croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, magnesium stearate, silicon dioxide, stearic acid

HEALTH CLAIM SECTION

NO: Milk, Egg, Fish, Crustacean Shellfish, Tree Nuts, Peanuts, Yeast, Artificial Colors, Flavors or Preservatives.

WARNINGS SECTION

Do not use if tamper-evident seal is broken or missing. Store at room temperature 590 - 860F (150 - 300C). Keep out of reach of children. If pregnant, breast-feeding or taking any medications, consult a physician before use. Discontinue use and consult a physician, if adverse reactions occur.

HEALTH CLAIM SECTION

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

HEALTH CLAIM SECTION

Distributed by:

Safrel Pharmaceuticals LLC

Bridgewater, NJ 08807

www.safrelpharma.com

Questions or comments?

Call 1-844-384-3723

9AM - 5PM Monday - Friday

HEALTH CLAIM SECTION

WARNING

If you are under medical supervision or using any tranquilizers or sedatives, seek the advice of your health care professional prior to using. Consult your healthcare professional before using ifyou have an autoimmune condition, depressive disorder or are pregnant or lactating. Not for use by children under 12 years of age. Do not take when operating machinery or driving a vehicle.

PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safrel Melatonin 3mg Tablets:

Helps establish normal sleep patterns 100%
Drug-free and non-habit forming melatonin is a nighttime sleep aid for occassional sleeplessness.
Vegan
Fast Dissolve

DIETARY SUPPLEMENT

Melatonin 3mg Tablets 60 Count

Principal Display Panel - 60 Vitamin Bottle LabelPrincipal Display Panel - 60 Vitamin Bottle Label

Melatonin 3mg Tablets 90 count

Principal Display Panel - 90 Vitamin Bottle LabelPrincipal Display Panel - 90 Vitamin Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199163melatonin 3 MG Oral TabletPSN1
199163melatonin 3 MG Oral TabletSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-634-60Safrel Melatonin60 in 1 BOTTLETABLET601
71309-634-90Safrel Melatonin90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-634SAFREL MELATONIN (MELATONIN) TABLET [SAFREL PHARMACEUTICALS, LLC.]12 package rows20200831_f8a2e032-7457-434e-bfea-84178bf1f544.zip

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
71309-63471309-634-60, 71309-634-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MelatoninJL5DK93RCLACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melatonin 1527MELATONINProfessional Complementary Health Formulaseb411c99-fe69-400d-b452-95d8d6d754b82026-01-08WarningsName fallback
generic name: MELATONIN
MELATONIN CORDMELATONINEnergique, Inc.9a59554b-14c4-4c79-9db1-0a38b3c152f22024-10-28WarningsName fallback
generic name: MELATONIN
Melatonin PhenolicMELATONINEnergique, Inc.895cb8a5-33ea-4764-86a6-1da513dcd2c12024-10-28WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.8951e5e9-5d8f-4808-b247-208760fae6562024-10-17WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINDeseret Biologicals, Inc.4ea9b3dc-a6f7-48b0-b0a7-ac2951bc575d2024-04-01WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.cd82eb5d-a44a-4512-ad65-0fffae70d1d02017-07-25WarningsName fallback
generic name: MELATONIN

Reported adverse events (FAERS/openFDA)#

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