Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0539-1 - Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated April 18, 2022
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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:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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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 liquidProduct 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)
