Spleenex

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:40

Label at a glance#

ProductSpleenex V
Active ingredientAMERICAN GINSENG, POTASSIUM GLUCONATE, GINKGO, MAGNESIUM GLUCONATE, SUS SCROFA PANCREAS, SUS SCROFA SPLEEN, SUS SCROFA STOMACH, GERMANIUM SESQUIOXIDE, COPPER, ZINC, OXOGLURIC ACID, ANHYDROUS CITRIC ACID, FUMARIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, MALIC ACID, PYRUVIC ACID, SUCCINIC ACID, NAPHTHOQUINE, ACONITIC ACID, (Z)-, SODIUM DIETHYL OXALACETATE
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 2 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): 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:

OTC - PURPOSE SECTION

May temporarily relieve stomach discomfort, diarrhea, and fever.**

**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 2 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 stomach discomfort, diarrhea, and fever.**

**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

SINCE 1987

HOMEOPATHIC REMEDY

SPLEENEX V

1 fl. oz. (30 ml)

Spleenex VSpleenex V

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0539-12024-10-30C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12024-01-30C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12022-04-18C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0539-12022-01-28C16284748780-1d6a99b39-531c-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0539-1SpleenexV30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0539SPLEENEX 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 [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20241101_effbaa07-239b-42f2-afd4-0eeeba7de1fd.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-053944911-0539-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML · Source PDF

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 VARALIA 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 OXALACETICUMEnergique, Inc.effbaa07-239b-42f2-afd4-0eeeba7de1fd2024-10-30WarningsExact identifier
ndc (package): 44911-0539-1
ndc (product): 44911-0539
ndc11 (package): 44911053901
spl id: f4520ea3-df0f-4508-b48c-e1e5dc898cbf
spl set id: effbaa07-239b-42f2-afd4-0eeeba7de1fd

Reported adverse events (FAERS/openFDA)#

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