NDC 44911-0500 Melatonin Pro

Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (pratensis)

NDC Product Code 44911-0500

NDC Code: 44911-0500

Proprietary Name: Melatonin Pro What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (pratensis) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44911 - Energique, Inc.
    • 44911-0500 - Melatonin Pro

NDC 44911-0500-1

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Melatonin Pro with NDC 44911-0500 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Melatonin Pro is calcarea carbonica, chamomilla, cocculus indicus, coffea cruda, ferrum phosphoricum, kali phosphoricum, magnesia carbonica, melatonin, natrum muriaticum, nux vomica, pulsatilla (pratensis). The product's dosage form is tablet and is administered via oral form.

Labeler Name: Energique, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Melatonin Pro Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/1
  • MATRICARIA CHAMOMILLA 12 [hp_X]/1
  • ANAMIRTA COCCULUS SEED 12 [hp_X]/1
  • ARABICA COFFEE BEAN 12 [hp_X]/1
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/1
  • DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]/1
  • MAGNESIUM CARBONATE 12 [hp_X]/1
  • MELATONIN 12 [hp_X]/1
  • SODIUM CHLORIDE 12 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/1
  • ANEMONE PRATENSIS 12 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Energique, Inc.
Labeler Code: 44911
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-07-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Melatonin Pro Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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.

Inactive Ingredients:

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

Questions:

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579   800.869.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYMELATONINPRO1 fl. oz. (30 ml)

* Please review the disclaimer below.

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