drug facts:

drug facts:
SPL v4
SPL
SPL Set ID cd82eb5d-a44a-4512-ad65-0fffae70d1d0
Route
oral
Published
Effective Date 2017-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
melatonin (6 [hp_X])
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2013-02-13
Description

Melatonin 6X, 12X, 30X, 12C, 30C.

Medication Information

Description

Melatonin 6X, 12X, 30X, 12C, 30C.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of fatigue, irritability, insomnia, and exhaustion.

Active Ingredients:

Melatonin 6X, 12X, 30X, 12C, 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

MELATONIN

HOMEOPATHIC

1 FL OZ (30 ml)

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.

Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of fatigue, irritability, insomnia, and exhaustion.

Active Ingredients: (ACTIVE INGREDIENTS:)

Melatonin 6X, 12X, 30X, 12C, 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

MELATONIN

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:43.861479 · Updated: 2026-03-14T23:14:41.895392