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Melatonin
Melatonin is an over-the-counter drug, made by BioActive Nutritional, Inc..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 1
For temporary relief of fatigue, irritability, insomnia, and exhaustion.
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrug02/09/2022MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer...Ultra Seal Corporation · 6 products · cGMP deviations
- Class IIDrug03/22/2017MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676Synergy Rx · Lack of Assurance of Sterility: There are also CGMP Deviations.
- Class IIDrug07/13/2016All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving...Reliable Rexall-A Compounding Pharmacy · Lack of Processing Controls
- Class IIDrug01/22/2014MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466Aidapak Services, LLC · 6 products · Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially...
Active ingredients
Melatonin 6X.
Purpose
INDICATIONS: For temporary relief of fatigue, irritability, insomnia, and exhaustion.
Uses
For temporary relief of fatigue, irritability, insomnia, and exhaustion.
Directions
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
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 cool, dry place.
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.
Inactive ingredients
Demineralized Water, 25% Ethanol
Questions?
Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Liquid | 6 [hp_X]/mL | oral | 2 |
Manufacturers and labels
2 FDA labels
- BioActive Nutritional, Inc.Shown hereLabel 10/17/2024 · NDC 43857-0511Full label
- BioActive Nutritional, Inc.Label 07/25/2017 · NDC 43857-0086Full label
Melatonin: common questions
- What is Melatonin used for?
- For temporary relief of fatigue, irritability, insomnia, and exhaustion.
- Is Melatonin a prescription drug?
- No. Melatonin is sold over the counter (OTC) without a prescription.
- Who makes Melatonin?
- BioActive Nutritional, Inc. lists Melatonin with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/17/2024 · Label text is shown as published by the manufacturer. Not medical advice