Melatonin by Deseret Biologicals, Inc. / Apotheca Company MELATONIN liquid

Melatonin by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT:

Melatonin 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to sleep issues and jet lag.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

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

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

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

KEEP OUT OF REACH OF CHILDREN:

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

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.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to sleep issues and jet lag.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070    www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-0771-1

HOMEOPATHIC

MELATONIN

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

MELATONIN 
melatonin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43742-0771
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X]  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: 43742-0771-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/08/2016

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43742-0771) , api manufacture(43742-0771) , label(43742-0771) , pack(43742-0771)