SYZYGIUM COMPOSITUM - strychnos ignatii seed, trinitrophenol, lycopodium clavatum spore, phosphoric acid, lactic acid, l-, wood creosote, claviceps purpurea sclerotium, arsenic trioxide, tubercidin, .alpha.-ketoglutaric acid, sulfuric acid, syzygium cumini seed, pork liver, sus scrofa pancreas, sodium sulfate, phlorizin and lead liquid
MediNatura 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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Syzygium Compositum Rx Oral Drop

DESCRIPTION

EAch 50 ml contains as active ingredients: Ignatia amara 4X, Picricum acidum 4X, Lycopodium clavatum 4X, Phosphoricum acidum 4X, Sarcolacticum acidum 4X, Kreosotum 6X, Secale cornutum 6X, Arsenicum album 8X, Curare 8X, A-Ketoglutaricum acidum 8X, Sulphuricum acidum 8X, Syzygium jambolanum 8X, Hepar suis 10X, Natrum sulphuricum 10X, Pancreas suis 10X, Phloridzinum 10X, Plumbum metallicum 18X 0.5 ml each. Inactive ingredients: Ethanol, purified water USP.

INDICATION AND USAGE

For the ancillary treatment of adult onset diabetes:

Stimulation of organ functionStimulation of enzyme systemsStimulation of peripheral circulation

DOSAGE AND ADMINISTRATION

Adults and Children above 11 years: 10 drops orally 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age

WARNINGS

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product. Keep this and all medicines out of the reach of children.

SYZYGIUM COMPOSITUM
strychnos ignatii seed and trinitrophenol and lycopodium clavatum spore and phosphoric acid and lactic acid, l- and wood creosote and claviceps purpurea sclerotium and arsenic trioxide and tubocurarine chloride and .alpha.-ketoglutaric acid and sulfuric acid and syzygium cumini seed and pork liver and sodium sulfate and sus scrofa pancreas and phlorizin and lead and liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:50114-6175
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	4 [hp_X] in 50 mL
TRINITROPHENOL (UNII: A49OS0F91S) (TRINITROPHENOL - UNII:A49OS0F91S)	TRINITROPHENOL	4 [hp_X] in 50 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	4 [hp_X] in 50 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	4 [hp_X] in 50 mL
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N)	LACTIC ACID, L-	4 [hp_X] in 50 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	6 [hp_X] in 50 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	6 [hp_X] in 50 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	8 [hp_X] in 50 mL
TUBERCIDIN (UNII: M351LCX45Y) (CHLORIDE ION - UNII:Q32ZN48698)	TUBERCIDIN	8 [hp_X] in 50 mL
.ALPHA.-KETOGLUTARIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	.ALPHA.-KETOGLUTARIC ACID	8 [hp_X] in 50 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF)	SULFURIC ACID	8 [hp_X] in 50 mL
SYZYGIUM CUMINI SEED (UNII: 820LSF646I) (SYZYGIUM CUMINI SEED - UNII:820LSF646I)	SYZYGIUM CUMINI SEED	8 [hp_X] in 50 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	10 [hp_X] in 50 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	10 [hp_X] in 50 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	8 [hp_X] in 50 mL
PHLORIZIN (UNII: CU9S17279X) (PHLORIZIN - UNII:CU9S17279X)	PHLORIZIN	10 [hp_X] in 50 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	18 [hp_X] in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-6175-4	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/1986	01/30/2013

Labeler - MediNatura Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
MediNatura Inc		102783016	manufacture(50114-6175)

Revised: 6/2015

Document Id: a95c24ba-0e5f-4725-b80c-9932097ffa5f

Set id: 3ef1815d-9be6-45ee-bb6f-26e6bef984a4

Version: 2

Effective Time: 20150615

MediNatura Inc