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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.