Melatonin Pro: Homeopathic Product Information

MELATONIN PRO- oyster shell calcium carbonate, crude, matricaria chamomilla, anamirta cocculus seed, arabica coffee bean, ferrosoferric phosphate, dibasic potassium phosphate, magnesium carbonate, melatonin, sodium chloride, strychnos nux-vomica seed and anemone pratensis tablet
Energique, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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)

Melatonin Pro
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 12 [hp_X]
ANAMIRTA COCCULUS SEED (ANAMIRTA COCCULUS SEED) ANAMIRTA COCCULUS SEED 12 [hp_X]
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 12 [hp_X]
FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 12 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (PHOSPHATE ION) DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE 12 [hp_X]
MELATONIN (MELATONIN) MELATONIN 12 [hp_X]
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 12 [hp_X]
ANEMONE PRATENSIS (ANEMONE PRATENSIS) ANEMONE PRATENSIS 12 [hp_X]
Inactive Ingredients
Ingredient Name Strength
SORBITOL
SILICON DIOXIDE
COPOVIDONE K25-31
MANNITOL
MICROCRYSTALLINE CELLULOSE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POWDERED CELLULOSE
Product Characteristics
Color white (Clear) Score no score
Shape capsule Size 21mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44911-0500-1 60 TABLET in 1 BOTTLE, PLASTIC None
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 Operations
Apotheca Company 844330915 manufacture (44911-0500), api manufacture (44911-0500), label (44911-0500), pack (44911-0500)

Revised: 05/2023 Energique, Inc.

HomeoLabels.com provides trustworthy package insert and label information about marketed homeopathic remedies as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by HomeoLabels.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

We source our database directly from the FDA's central repository of homeopathic remedy labels and package inserts, under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.