The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Melatonin Pro (NDC 44911-0500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(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.
May temporarily help to support healthy sleep and circadian rhythm.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May temporarily help to support healthy sleep and circadian rhythm.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Adults take one tablet 30 minutes before bedtime or as directed by a health professional only. Hold tablet in mouth until dissolved and swallow.
Advantol 300, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose, Vegetable Capsule (Cellulose).
Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579 800.869.8078
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
MELATONIN
PRO
1 fl. oz. (30 ml)
* Please review the disclaimer below.
