MELATONIN FORTE- melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypothalamus, lithium carbonicum, magnesia carbonica, pineal, pituitary, spray
Apotheca Company

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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Melatonin Forte

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.

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

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.

DIRECTIONS: Three sprays per day. Hold in mouth for two minutes. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS: Citric acid, Demineralized water, Glycerin, Sodium benzoate.

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 imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic
MELATONIN FORTE
1 FL OZ (30 ml)

Melatonin Forte

MELATONIN FORTE
melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypothalamus, lithium carbonicum, magnesia carbonica, pineal, pituitary, spray

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X] in 1 mL
NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK)	NADIDE	6 [hp_X] in 1 mL
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	6 [hp_X] in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	6 [hp_X] in 1 mL
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6 [hp_X] in 1 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7)	BOS TAURUS HYPOTHALAMUS	8 [hp_X] in 1 mL
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	8 [hp_X] in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	8 [hp_X] in 1 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	8 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0640-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/18/2011	11/16/2016

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

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

Revised: 12/2015

Document Id: 68e164ff-21f5-481d-9c13-0c22dc8f1819

Set id: 96527d62-16ed-4e3a-bc72-d70ce2af2e8c

Version: 3

Effective Time: 20151230

Apotheca Company