MELATONIN- melatonin, liquid

Melatonin by

Drug Labeling and Warnings

Melatonin by is a Homeopathic medication manufactured, distributed, or labeled by Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Melatonin 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C.

PURPOSE

INDICATIONS:  For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

WARNINGS

WARNINGS:  Keep out of reach of children.  In case of overdose, contact physician or Poison Control Center right away

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection."  Do not use if seal is broken or missing.

DOSAGE & ADMINISTRATION

DIRECTIONS:  1-10 drops under the tongue, 3 times a day or as directed by a health professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, contact physician or Poison Control Center right away.

INDICATIONS & USAGE

INDICATIONS:  For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

QUESTIONS

Dist. By:

Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070

www.desbio.com

PRINCIPAL DISPLAY PANEL

DESBIO

NDC: 57520-0729-1

HOMEOPATHIC

MELATONIN

1 FL OZ (30 ML)

INGREDIENTS AND APPEARANCE

MELATONIN 
melatonin, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0729
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	200 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57520-0729-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/15/2011

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture