MELATONIN PRO (calcarea carbonica, chamomilla, cocculus indicus, coffea cruda, ferrum phosphoricum, kali phosphoricum, magnesia carbonica, melatonin, natrum muriaticum, nux vomica, pulsatilla- pratensis tablet

Melatonin Pro by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each tablet): 0.09% of Calcarea Carbonica 12X, Chamomilla 12X, Cocculus Indicus 12X, Coffea Cruda 12X, Ferrum Phosphoricum 12X, Kali Phosphoricum 12X, Magnesia Carbonica 12X, Melatonin 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Pulsatilla (Pratensis) 12X.

INDICATIONS:

May temporarily help to support healthy sleep and circadian rhythm.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

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

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Not to be taken by pregnant or lactating women. If you are taking MAO inhibitors, immunosuppressant drugs, anti-coagulation therapy, or anti-hypertensive medication, or have an autoimmune, seizure, psychiatric or depressive disorder consult your healthcare professional before using this product. Long-term use of melatonin has not been studied. May cause drowsiness. Do not use before or while operating a motor vehicle or heavy machinery.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults take one tablet 30 minutes before bedtime or as directed by a health professional only. Hold tablet in mouth until dissolved and swallow.

INDICATIONS:

May temporarily help to support healthy sleep and circadian rhythm.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Advantol 300, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose, Vegetable Capsule (Cellulose).

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
MELATONIN

PRO
1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

MELATONIN PRO 
calcarea carbonica, chamomilla, cocculus indicus, coffea cruda, ferrum phosphoricum, kali phosphoricum, magnesia carbonica, melatonin, natrum muriaticum, nux vomica, pulsatilla (pratensis) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	12 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	12 [hp_X]
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	12 [hp_X]
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	12 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

Product Characteristics
Color	white (Clear)	Score	no score
Shape	capsule	Size	21mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0500-1	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/07/2019

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0500) , api manufacture(44911-0500) , label(44911-0500) , pack(44911-0500)