Spleenex

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:28:39

Label at a glance#

ProductSpleenex VH
Active ingredientAMERICAN GINSENG, GINKGO, SUS SCROFA PANCREAS, SUS SCROFA SPLEEN, SUS SCROFA STOMACH, GERMANIUM SESQUIOXIDE, COBALT, NICKEL, ZINC, OXOGLURIC ACID, ANHYDROUS CITRIC ACID, FUMARIC ACID, MALIC ACID, PYRUVIC ACID, SUCCINIC ACID, NAPHTHOQUINE, BARIUM CARBONATE, PHOSPHORIC ACID, ACONITIC ACID, (Z)-, MAGNESIUM GLUCONATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(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:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINDE 1987

HOMEOPATHIC REMEDY

SPLEENEX VH

1 fl. oz. (30 ml)

Spleenex VHSpleenex VH

Spleenex VHSpleenex VH

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0294-12024-10-30C16284748780-1d6a99b39-ee44-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0294-12022-01-28C16284748780-1d6a99b39-ee44-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0294-1SpleenexVH30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0294SPLEENEX 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.]5Current NDC, Legacy NDC, 1 package rows20241101_54e2c88e-2483-4c38-86e5-19e218e713ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITIC ACID, CIS-ACTIVE INGREDIENTOF5471ZHRR1
AMERICAN GINSENGACTIVE INGREDIENT8W75VCV53Q1
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL1
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ81
COBALTACTIVE INGREDIENT3G0H8C93621
FUMARIC ACIDACTIVE INGREDIENT88XHZ131311
GERMANIUM SESQUIOXIDEACTIVE INGREDIENT96WE91N25T1
GINKGOACTIVE INGREDIENT19FUJ2C58T1
MAGNESIUM GLUCONATEACTIVE INGREDIENTT42NAD2KHC1
MALIC ACIDACTIVE INGREDIENT817L1N4CKP1
NAPHTHOQUINEACTIVE INGREDIENTTRY8UD4E2H1
NICKELACTIVE INGREDIENT7OV03QG2671
OXOGLURIC ACIDACTIVE INGREDIENT8ID597Z82X1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
PYRUVIC ACIDACTIVE INGREDIENT8558G7RUTR1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
SUCCINIC ACIDACTIVE INGREDIENTAB6MNQ6J6L1
SUS SCROFA PANCREASACTIVE INGREDIENT9Y3J3362RY1
SUS SCROFA SPLEENACTIVE INGREDIENT92AMN5J79Y1
SUS SCROFA STOMACHACTIVE INGREDIENTT0920P9Z9A1
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
.ALPHA.-KETOGLUTARIC ACIDACTIVE MOIETY8ID597Z82X1
ACONITIC ACID, CIS-ACTIVE MOIETYOF5471ZHRR1
AMERICAN GINSENGACTIVE MOIETY8W75VCV53Q1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
BARIUM CATIONACTIVE MOIETYV645272HLN1
COBALTACTIVE MOIETY3G0H8C93621
FUMARIC ACIDACTIVE MOIETY88XHZ131311
GERMANIUM SESQUIOXIDEACTIVE MOIETY96WE91N25T1
GINKGOACTIVE MOIETY19FUJ2C58T1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
MALIC ACIDACTIVE MOIETY817L1N4CKP1
NAPHTHOQUINEACTIVE MOIETYTRY8UD4E2H1
NICKELACTIVE MOIETY7OV03QG2671
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PYRUVIC ACIDACTIVE MOIETY8558G7RUTR1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
SUCCINIC ACIDACTIVE MOIETYAB6MNQ6J6L1
SUS SCROFA PANCREASACTIVE MOIETY9Y3J3362RY1
SUS SCROFA SPLEENACTIVE MOIETY92AMN5J79Y1
SUS SCROFA STOMACHACTIVE MOIETYT0920P9Z9A1
ZINCACTIVE MOIETYJ41CSQ7QDS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-029444911-0294-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spleenex VHARALIA 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, PHOSPHORUSEnergique, Inc.54e2c88e-2483-4c38-86e5-19e218e713ae2024-10-30WarningsExact identifier
ndc (package): 44911-0294-1
ndc (product): 44911-0294
ndc11 (package): 44911029401
spl id: 99ef1e8f-d0f2-463d-afea-931b65a3abea
spl set id: 54e2c88e-2483-4c38-86e5-19e218e713ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.