SPLEENEX VH- aralia quinquefolia, ginkgo biloba, pancreas suis, spleen (suis), stomach (suis), germanium sesquioxide, cobaltum metallicum, niccolum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, malic acid, pyruvic acid, succinicum acidum, naphthoquinone, baryta carbonica, phosphoricum acidum, aconiticum acidum, cis, magnesium gluconicum dihydricum, nux vomica, phosphorus liquid
Energique, 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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Drug Facts:

ACTIVE INGREDIENTS:

(in each drop): 6.23% Baryta Carbonica 12X, Cobaltum Metallicum 12X, Niccolum Metallicum 12X, Phosphoricum Acidum 12X; Nux Vomica 12X, 30x, Phosphorus 12X, 30X. 1.85% of alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X; Aralia Quinquefolia 12X, Zincum Metallicum 12X; Fumaricum Acidum 12X, 30X, Magnesium Gluconicum Dihydricum 12X, 30X, Malic Acid 12X, 30X, Pancreas Suis 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X, Succinicum Acidum 12X, 30X; Aconiticum Acidum, Cis 30X, Naphthochinonum 30X. 0.10% of Cobaltum Metallicum 8X, Niccolum Metallicum 8X. 0.007% of Aralia Quinquefolia 3X, 6X; Ginkgo Biloba 6X, Pancreas Suis 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Fumaricum Acidum 8X, Germanium Sesquioxide 8X, Malic Acid 8X, Succinicum Acidum 8X, Zincum Metallicum 8X; Naphthochinonum 9X, 12X; Aconiticum Acidum, Cis 12X.

INDICATIONS:

May temporarily relieve heaviness and fullness after eating little, stomach pain, and weak digestion.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

If pregnant or breast-feeding, ask a health 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.

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.

DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve heaviness and fullness after eating little, stomach pain, weak digestion.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINDE 1987

HOMEOPATHIC REMEDY

SPLEENEX VH

1 fl. oz. (30 ml)

Spleenex VH

SPLEENEX VH
aralia quinquefolia, ginkgo biloba, pancreas suis, spleen (suis), stomach (suis), germanium sesquioxide, cobaltum metallicum, niccolum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, malic acid, pyruvic acid, succinicum acidum, naphthoquinone, baryta carbonica, phosphoricum acidum, aconiticum acidum, cis, magnesium gluconicum dihydricum, nux vomica, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0294
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	3 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [hp_X] in 1 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	6 [hp_X] in 1 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y)	SUS SCROFA SPLEEN	6 [hp_X] in 1 mL
SUS SCROFA STOMACH (UNII: T0920P9Z9A) (SUS SCROFA STOMACH - UNII:T0920P9Z9A)	SUS SCROFA STOMACH	6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	8 [hp_X] in 1 mL
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362)	COBALT	8 [hp_X] in 1 mL
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267)	NICKEL	8 [hp_X] in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	8 [hp_X] in 1 mL
OXOGLURIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	OXOGLURIC ACID	8 [hp_X] in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	8 [hp_X] in 1 mL
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	8 [hp_X] in 1 mL
MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP)	MALIC ACID	8 [hp_X] in 1 mL
PYRUVIC ACID (UNII: 8558G7RUTR) (PYRUVIC ACID - UNII:8558G7RUTR)	PYRUVIC ACID	8 [hp_X] in 1 mL
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L)	SUCCINIC ACID	8 [hp_X] in 1 mL
NAPHTHOQUINE (UNII: TRY8UD4E2H) (NAPHTHOQUINE - UNII:TRY8UD4E2H)	NAPHTHOQUINE	9 [hp_X] in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
ACONITIC ACID, (Z)- (UNII: OF5471ZHRR) (ACONITIC ACID, (Z)- - UNII:OF5471ZHRR)	ACONITIC ACID, (Z)-	12 [hp_X] in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [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:44911-0294-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/11/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/11/2015

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0294) , api manufacture(44911-0294) , label(44911-0294) , pack(44911-0294)