SAFREL MELATONIN- melatonin tablet

Safrel Melatonin by

Drug Labeling and Warnings

Safrel Melatonin by is a Other medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

SUPPLEMENT FACTS
Suggested Use: For adults, chew two gummies 30 minutes prior to sleep event. Gummy should be chewed before swallowing.
Serving Size: 2 gummies	Servings 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

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

WARNINGS

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

*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

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

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

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

Melatonin 3mg Tablets 90 count

INGREDIENTS AND APPEARANCE

SAFREL MELATONIN 
melatonin tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71309-634
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Melatonin (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	Melatonin	3 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71309-634-60	60 in 1 BOTTLE
2	NHRIC:71309-634-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		08/30/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	4 mm
scoring	1

Labeler - Safrel Pharmaceuticals, LLC. (080566287)