Download FDA Structured Product Label as PDF

MELATONIN FORTE- melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum
s ulphuricum, hypothalamus (s uis ), lithium carbonicum, magnes ia carbonica, pineal (s uis ),
pituitaria glandula (s uis ) s pray
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.
---------Drug Facts :
ACTIVE INGREDIENTS:
Melatonin 6X, Nadidum 6X, Niacin 6X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X,
Hypothalamus (Suis) 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Pineal (Suis) 8X, Pituitaria
Glandula (Suis) 8X.
INDICATIONS:
For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance
in menstrual cycle.
WARNINGS:
If pregnant or breas t-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.
INACTIVE INGREDIENTS:
Citric acid, Demineralized water, Glycerin, Sodium benzoate.
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 imbalances in menstruation and ovulation, insomnia, dysmenorrhea and
imbalance in menstrual cycle.
Dis tributed by:
BIOACTIVE NUTRITIONAL
Melbourne, FL 32935
For Nutritional Information write:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
PACKAGE LABEL DISPLAY:
BIOActive Nutritional
MELATONIN FORTE
HOMEOPATHIC
1 FL OZ (30 ml)
MELATONIN FORTE
melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypothalamus (suis), lithium
carbonicum, magnesia carbonica, pineal (suis), pituitaria glandula (suis) spray
Product Information
Prod uct T yp e
HUMAN O TC DRUG
Route of Ad minis tration
O RAL
NDC:438 57-0 0 20
Ite m Cod e (S ource )
Active Ing redient/Active Moiety
Ing redient Name
Basis o f Streng th
Streng th
MELATO NIN (UNII: JL5DK9 3RCL) (MELATO NIN - UNII:JL5DK9 3RCL)
MELATO NIN
6 [hp_X]
in 1 mL
NADIDE (UNII: 0 U46 U6 E8 UK) (NADIDE - UNII:0 U46 U6 E8 UK)
NADIDE
6 [hp_X]
in 1 mL
NIACIN (UNII: 26 79 MF6 8 7A) (NIACIN - UNII:26 79 MF6 8 7A)
NIACIN
6 [hp_X]
in 1 mL
PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV) (PYRIDO XINE -
PYRIDO XINE
6 [hp_X]
UNII:KV2JZ1BI6 Z)
HYDRO CHLO RIDE
in 1 mL
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATIO N UNII:13S1S8 SF37)
ZINC CATIO N
6 [hp_X]
in 1 mL
SUS SCRO FA HYPO THALAMUS (UNII: N6 R0 8 56 Z79 ) (SUS SCRO FA HYPO THALAMUS - SUS SCRO FA
UNII:N6 R0 8 56 Z79 )
HYPO THALAMUS
8 [hp_X]
in 1 mL
LITHIUM CARBO NATE (UNII: 2BMD2GNA4V) (LITHIUM CATIO N - UNII:8 H8 Z5UER6 6 )
LITHIUM CARBO NATE
8 [hp_X]
in 1 mL
MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA) (CARBO NATE IO N UNII:7UJQ 5O PE7D)
MAGNESIUM
CARBO NATE
8 [hp_X]
in 1 mL
SUS SCRO FA PINEAL GLAND (UNII: 0 50 Q Z2EDK7) (SUS SCRO FA PINEAL GLAND UNII:0 50 Q Z2EDK7)
SUS SCRO FA PINEAL
GLAND
8 [hp_X]
in 1 mL
SUS SCRO FA PITUITARY GLAND (UNII: E8 S8 7O 6 6 0 T) (SUS SCRO FA PITUITARY
GLAND - UNII:E8 S8 7O 6 6 0 T)
SUS SCRO FA PITUITARY
GLAND
8 [hp_X]
in 1 mL
Inactive Ing redients
Ing redient Name
Streng th
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 Q P)
WATER (UNII: 0 59 Q F0 KO 0 R)
GLYCERIN (UNII: PDC6 A3C0 O X)
SO DIUM BENZO ATE (UNII: O J245FE5EU)
Packag ing
#
1
Item Co de
Marketing Start
Date
Packag e Descriptio n
NDC:438 57-0 0 20 - 30 mL in 1 BO TTLE, SPRAY; Type 0 : No t a Co mbina tio n
1
Pro duc t
Marketing End
Date
0 4/0 6 /20 16
Marketing Information
Marke ting Cate gory
Ap p lication Numb e r or Monograp h Citation
una ppro ve d ho me o pa thic
Labeler -
Marke ting S tart Date
Marke ting End Date
0 5/0 4/20 12
BioActive Nutritional, Inc. (624980496)
Registrant -
Apotheca Company (844330915)
Establishment
Name
Apo the c a
Co mpa ny
Revised: 4/2016
Ad d re s s
ID/FEI
Bus ine s s Op e rations
8 44330 9 15
ma nufa c ture (438 57-0 0 20 ) , a pi ma nufa c ture (438 57-0 0 20 ) , la be l(438 57-0 0 20 ) , pa c k(438 570 0 20 )
BioActive Nutritional, Inc.