SPLEENEX V (aralia quinquefolia, potassium gluconate, ginkgo biloba, magnesium gluconicum dihydricum, pancreas suis, spleen (suis), stomach- suis, germanium sesquioxide, cuprum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, magnesia phosphorica, malicum acidum, pyruvic acid, succinicum acidum, naphthochinonum, aconiticum acidum, cis-, natrum oxalaceticum liquid

Spleenex by

Drug Labeling and Warnings

Spleenex by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each drop): 2.47% of Ginkgo Biloba 6X; Aralia Quinquefolia 6X, 12X, 30X; Alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Fumaricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X, Succinicum Acidum 8X, 12X, 30X; Cuprum Metallicum 12X, Zincum Metallicum 12X; Magnesia Phosphorica 12X, 30X, Magnesium Gluconicum Dihydricum 12X 30X, Malicum Acidum 12X, 30X, Naphthoquinone 12X, 30X, Natrum Oxalaceticum 12X, 30X, Pancreas Suis 12X, 30X, Potassium Gluconate 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X; Aconiticum Acidum, Cis 30X. 0.10% of Aralia Quinquefolia 3X, Potassium Gluconate 3X; Magnesium Gluconicum Dihydricum 6X, Pancreas Suis 6X, Potassium Gluconate 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Cuprum Metallicum 8X, Germanium Sesquioxide 8X, Magnesia Phosphorica 8X, Malicum Acidum 8X, Zincum Metallicum 8X; Naphthoquinone 9X; Aconiticum Acidum, Cis 12X.

INDICATIONS:

May temporarily reliee stomach discomfor, diarrhea, and fever.**

**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 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily reliee stomach discomfor, diarrhea, and fever.**

**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

SINCE 1987

HOMEOPATHIC REMEDY

SPLEENEX V

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

SPLEENEX  V
aralia quinquefolia, potassium gluconate, ginkgo biloba, magnesium gluconicum dihydricum, pancreas suis, spleen (suis), stomach (suis), germanium sesquioxide, cuprum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, magnesia phosphorica, malicum acidum, pyruvic acid, succinicum acidum, naphthochinonum, aconiticum acidum, cis-, natrum oxalaceticum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0539
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	3 [hp_X]  in 1 mL
POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM GLUCONATE	3 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [hp_X]  in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	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
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	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
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	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
ACONITIC ACID, (Z)- (UNII: OF5471ZHRR) (ACONITIC ACID, (Z)- - UNII:OF5471ZHRR)	ACONITIC ACID, (Z)-	12 [hp_X]  in 1 mL
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7)	SODIUM DIETHYL OXALACETATE	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0539-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/19/2020

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0539) , api manufacture(44911-0539) , label(44911-0539) , pack(44911-0539)