Dosage and administration
Adults take one capsule 30 minutes before bedtime or as directed by a health professional only.
Melatonin Pro
- Manufacturer
- Energique, Inc. | Apotheca Company
- Effective date
- 2023-07-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:53
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, PULSATILLA PRATENSIS WHOLE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS:
(in each capsule): 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:
In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
Adults take one capsule 30 minutes before bedtime or as directed by a health professional only.
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:
Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose, Silicone Dioxide, Sorbitol, 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
60 VEGETABLE CAPSULES
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44911-0500-1 | 2022-03-10 | C162847 | 48780-1 | ba0f9c33-12e4-a910-e053-dadaa90a0b85 | DRUG FACTS: |
| 44911-0500-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12e4-a910-e053-dadaa90a0b85 | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44911-0500-1 | Melatonin Pro | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44911-0500 | MELATONIN PRO (CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)) TABLET [ENERGIQUE, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230722_1f374642-83f7-4e64-b330-0f6ef21000a9.zip |
Products#
Every source-derived product name is available through these pages.
- Melatonin Pro
- Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- MATRICARIA CHAMOMILLA
- ANAMIRTA COCCULUS SEED
- ARABICA COFFEE BEAN
- FERROSOFERRIC PHOSPHATE
- DIBASIC POTASSIUM PHOSPHATE
- PHOSPHATE ION
- MAGNESIUM CARBONATE
- CARBONATE ION
- MELATONIN
- SODIUM CHLORIDE
- CHLORIDE ION
- STRYCHNOS NUX-VOMICA SEED
- PULSATILLA PRATENSIS WHOLE
- SORBITOL
- SILICON DIOXIDE
- COPOVIDONE K25-31
- CROSPOVIDONE, UNSPECIFIED
- MANNITOL
- MICROCRYSTALLINE CELLULOSE
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- POWDERED CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 44911-0500 | 44911-0500-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Melatonin Pro | CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS) | Energique, Inc. | 1f374642-83f7-4e64-b330-0f6ef21000a9 | 2023-07-19 | Warnings | 44911-0500-1 44911-0500 44911050001 bdfbe914-ba46-48a2-885f-a5c8b74c8f7b 1f374642-83f7-4e64-b330-0f6ef21000a9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.