Description

Indication & Scope

A melatonin-containing health food intended for adults with poor sleep conditions. The registered health function is described as based on animal-experiment evaluation. It is not intended to diagnose, treat, or cure disease.

Mechanism:Melatonin is a hormone naturally produced by the pineal gland. It helps regulate the body’s sleep–wake/circadian rhythm and the timing of sleep onset.
Drug class:Melatonin / sleep-related dietary supplement. Not classified as a pharmaceutical drug.
Clinical use:Used as a health-food supplement for people with poor sleep conditions. It should not be considered a substitute for medical evaluation or treatment of persistent insomnia.

Specification

Generic Name	Melatonin Tablets
Brand Name	BY-HEALTH
Ingredient	Melatonin; excipients include microcrystalline cellulose, magnesium stearate and film-coating materials
Dosage Form	Tablet
Package	24 g; 400 mg/tablet × 60 tablets
Conditions Treated	Not a drug; health function: improving sleep / for people with poor sleep conditions
Taboos	Not suitable for children/adolescents, pregnant women or breastfeeding women. People with autoimmune symptoms or hyperthyroidism should use only after professional advice.
Place of origin	Zhuhai, Guangdong, China
Prescription type	Health food; neither prescription medicine nor OTC medicine
Storage Conditions	Store in a cool, dry place
Manufacturer	BY-HEALTH Co., Ltd.
Registration Authority	Former China food/health-food regulatory system; current regulatory authority: State Administration for Market Regulation (SAMR)
Approval Number	G20150889
Approval Date	2020-11-24
Shelf Life	24 months

How to use ?

Recommended Dose: 1 tablet once daily.

Time: The product information specifies once daily; some current retail instructions recommend taking it approximately 30 minutes before bedtime.

Instructions for use: Take orally with water. Do not exceed the recommended intake. This product cannot replace medicines.

Interaction: Melatonin may have additive sedative effects with alcohol or sedative medicines. It may also interact with certain medicines, including anticoagulants, anticonvulsants and medicines affecting the central nervous system. People taking regular medication should consult a healthcare professional before use.

Side effects: Possible effects include daytime drowsiness, dizziness, headache, nausea and vivid dreams. Avoid driving, operating machinery or performing hazardous work after taking it if drowsiness occurs. The product information specifically advises against use immediately before or during driving/mechanical work.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

Is this a medicine?

No. BY-HEALTH Melatonin Tablets are registered as a health food, not a pharmaceutical drug. They should not be used as a substitute for treatment of insomnia or other medical conditions.

What is the purpose of the product?

Its registered health function is improving sleep, and it is intended for people whose sleep condition is not optimal.

Does “400 mg” mean each tablet contains 400 mg of melatonin?

No. 400 mg refers to the tablet specification. The registered formulation contains 0.56 g melatonin per 100 g, equivalent to approximately 2.24 mg melatonin per 400 mg tablet.

Who should not use it?

The registered product is not suitable for children/adolescents, pregnant women or breastfeeding women. People with autoimmune symptoms or hyperthyroidism should seek professional advice before use.