Spleenex Liquid
FDA Label NDC 44911-0294

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Spleenex (NDC 44911-0294). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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.

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.

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)

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