Melatonin Forte
DRUG FACTS:
410861ef-3f55-4a09-888e-2123b820f878
HUMAN OTC DRUG LABEL
May 14, 2025
BioActive Nutritional, Inc.
DUNS: 624980496
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Melatonin, Nadidum, Niacin, Pyridoxinum Hydrochloricum, Zincum Sulphuricum, Hypophysis Suis, Hypothalamus (Suis), Lithium Carbonicum, Magnesia Carbonica, Pineal (Suis)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL DISPLAY:
BIOActiveNutritional
MELATONIN FORTE
HOMEOPATHIC
1 FL OZ (30 ml)
INDICATIONS & USAGE SECTION
USES:
For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Hypophysis Suis 8X, Hypothalamus 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Melatonin 6X, Nadidum 6X, Niacin 6X, Pineal 8X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X.
OTC - PURPOSE SECTION
PURPOSE:
Hypophysis Suis – heavy menses,** Hypothalamus – hormonal regulation,** Lithium Carbonicum - irritability,** Magnesia Carbonica – trouble sleeping,** Melatonin – difficulty sleeping,** Nadidum - fatigue,** Niacin - antioxidant,** Pineal – hormonal regulation,** Pyridoxinum Hydrochloricum – night sweats,** Zincum Sulphuricum – abdomen pain**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS SECTION
WARNINGS:
If pregnant or breast-feeding, ask a health care professional before use.
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.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
• Three sprays per day.
• Hold in mouth for two minutes.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
Citric Acid, Demineralized Water, Ethanol 0.32%, Glycerin, Sodium Benzoate.
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.
OTC - QUESTIONS SECTION
QUESTIONS:
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
1-800-288-9525