Prostatone Liquid
FDA Label NDC 44911-0494

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 Prostatone (NDC 44911-0494). 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): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.

Indications:

May temporarily relieve pain down thighs during efforts to urinate, great straining and constant urging when urinating.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve pain down thighs during efforts to urinate, great straining and constant urging when urinating.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breastfeeding, 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   800.868.8078

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PROSTATONE

1 fl. oz. (30 ml)

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