FDA.reportPublic FDA data

Melatonin Pro

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:33:50

Label at a glance#

ProductMelatonin Pro
Active ingredientOYSTER 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, ANEMONE PRATENSIS
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(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:

OTC - PURPOSE SECTION

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

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

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Advantol 300, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
MELATONIN

PRO
1 fl. oz. (30 ml)

Melatonin ProMelatonin Pro

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-049144911-0491-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
MELATONINJL5DK93RCLACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ANEMONE PRATENSIS8E272251DIACTIB
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
COPOVIDONE K25-31D9C330MD8BIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ea9a1fd-e7b3-4b85-b1d5-bb35858cd231fc499d20-3c05-43f6-875c-3a3474df03ce2020-04-28WarningsExact identifier
spl id: 0ea9a1fd-e7b3-4b85-b1d5-bb35858cd231
spl set id: fc499d20-3c05-43f6-875c-3a3474df03ce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.