Histatone Liquid
FDA Label NDC 44911-0580

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 Histatone (NDC 44911-0580). 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): 16.62% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Solidago Virgaurea 12X; 0.10% of Allium Sativum 3X, Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X.

Indications:

For temporary relief of hay fever, sinus, cough, bronchial irritation, itching and burning.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of hay fever, sinus, cough, bronchial irritation, itching and burning.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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, 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

SINCE 1987

HOMEOPATHIC REMEDY

HISTATONE

1 fl. oz. (30 ml)

* Please review the disclaimer below.