Melatonin forte spray

Otc - active ingredient section

ACTIVE INGREDIENTS:Melatonin 6X, Nadidum 6X, Niacin 6X, Pyridoxinum hydrochloricum 6X, Zincum sulphuricum 6X, Hypothalamus 8X, Lithium carbonicum 8X, Magnesia carbonica 8X, Pineal suis 8X, Pituitary suis 8X.



Otc - purpose section

INDICATIONS:For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.


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. Consult a physician for use in children under 12 years of age.


Inactive ingredient section

INACTIVE INGREDIENTS:Citric acid, Demineralized water, 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.


Indications & usage section

INDICATIONS:For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.


Otc - questions section

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc

1803 N. Wickham Rd.

Melbourne, FL 32935


Ingredients and appearance - Product information

Melatonin forte spray- Melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypothalamus, lithium carbonicum, magnesia carbonica, pineal, pituitary,

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 57520-0640
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Melatonin ( UNII: JL5DK93RCL)( Melatonin - UNII: JL5DK93RCL ) 6 [hp_X]in 1 mL
Nadide ( UNII: 0U46U6E8UK)( Nadide - UNII: 0U46U6E8UK ) 6 [hp_X]in 1 mL
Niacin ( UNII: 2679MF687A)( Niacin - UNII: 2679MF687A ) 6 [hp_X]in 1 mL
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 6 [hp_X]in 1 mL
Zinc sulfate heptahydrate ( UNII: N57JI2K7WP)( Zinc cation - UNII: 13S1S8SF37 ) 6 [hp_X]in 1 mL
Bos taurus hypothalamus ( UNII: S6G2NLH4Y7)( Bos taurus hypothalamus - UNII: S6G2NLH4Y7 ) 8 [hp_X]in 1 mL
Lithium carbonate ( UNII: 2BMD2GNA4V)( Lithium cation - UNII: 8H8Z5UER66 ) 8 [hp_X]in 1 mL
Magnesium carbonate ( UNII: 0E53J927NA)( Carbonate ion - UNII: 7UJQ5OPE7D ) 8 [hp_X]in 1 mL
Sus scrofa pineal gland ( UNII: 050QZ2EDK7)( Sus scrofa pineal gland - UNII: 050QZ2EDK7 ) 8 [hp_X]in 1 mL
Sus scrofa pituitary gland ( UNII: E8S87O660T)( Sus scrofa pituitary gland - UNII: E8S87O660T ) 8 [hp_X]in 1 mL

Inactive Ingredients

Ingredient Name Code
Citric acid monohydrate ( UNII: 2968PHW8QP)
Glycerin ( UNII: PDC6A3C0OX)
Sodium benzoate ( UNII: OJ245FE5EU)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA

Labeler - Apotheca Company( 844330915)

Establishment

Name ID/FEI Business Operations
Apotheca Company 844330915 manufacture( 57520-0640), api manufacture( 57520-0640), label( 57520-0640), pack( 57520-0640)

Package label display:

BioActive Homeopathic
MELATONIN FORTE
1 FL OZ (30 ml)