MELATONIN- melatonin liquid 
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

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

INDICATIONS:

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

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.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

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.

INDICATIONS:

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

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

MELATONIN

HOMEOPATHIC

1 FL OZ (30 ml)

Melatonin

MELATONIN 
melatonin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0086-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/13/2013
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0086) , api manufacture(43857-0086) , label(43857-0086) , pack(43857-0086)

Revised: 7/2017
Document Id: e189499d-9da3-43fc-8a0b-9d5dd0923b11
Set id: cd82eb5d-a44a-4512-ad65-0fffae70d1d0
Version: 4
Effective Time: 20170725
 
BioActive Nutritional, Inc.