FNG II- echinacea angustifolia, hydrastis canadensis, lomatium, nasturtium aquaticum, tabebuia impetiginosa, iodium, adrenalinum, argentum metallicum, thymus, thyroidinum, phosphoricum acidum, candida albicans, lycopodium clavatum, pulsatilla, sepia liquid
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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Drug Facts:

Active Ingredients: Echinacea Angustifolia 3X, Hydrastis Canadensis 3X, Lomatium 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Iodium 6X, Adrenalinum 8X, Argentum Metallicum 8X, Thymus 8X, Thyroidinum 8X, Phosphoricum Acidum 12X, Candida Albicans 12X, 30X, Lycopodium Clavatum 30X, Pulsatilla 30X, Sepia 30X.

Indications: For temporary relief of bloating of the stomach, flatulence, and allergic rhinitis.

WARNINGS: If pregnant or breast-feeding, ask a health care professional before use.

Keep our 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.

KEEP OUT OF REACH OF CHILDREN:

Keep our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS & USAGE SECTION:

For temporary relief of bloating of the stomach, flatulence, and allergic rhinitis.

Inactive Ingredients: Demineralized Water, 25% Ethanol

Distributed By:

BioActive Nutritional

Melbourne, FL 32935

For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

FNG II

1 FL OZ (30 ML)

FNG II

FNG II
echinacea angustifolia, hydrastis canadensis, lomatium, nasturtium aquaticum, tabebuia impetiginosa, iodium, adrenalinum, argentum metallicum, thymus, thyroidinum, phosphoricum acidum, candida albicans, lycopodium clavatum, pulsatilla, sepia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0099
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
LOMATIUM DISSECTUM ROOT (UNII: 5329928G5N) (LOMATIUM DISSECTUM ROOT - UNII:5329928G5N)	LOMATIUM DISSECTUM ROOT	3 [hp_X] in 1 mL
TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (TABEBUIA IMPETIGINOSA BARK - UNII:6GLA1946WX)	TABEBUIA IMPETIGINOSA BARK	3 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	6 [hp_X] in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	8 [hp_X] in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	8 [hp_X] in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	8 [hp_X] in 1 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	8 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X] in 1 mL
RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676) (RORIPPA NASTURTIUM-AQUATICUM - UNII:YH89GMV676)	RORIPPA NASTURTIUM-AQUATICUM	3 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0099-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2010

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0099) , api manufacture(57520-0099) , label(57520-0099) , pack(57520-0099)