Throatspray
FDA Label NDC 44911-0737

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 Throatspray (NDC 44911-0737). 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:, purpose:, warnings:, keep out of reach of children:, directions:, indications:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

(in each spray): 6.67% of Apis Mellifica 12X, Baptisia Tinctoria 3X, Belladonna 12X, Echinacea 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Hepar Sulphuris Calcareum 15X, Hydrastis Canadensis 6X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Myrrha 2X, Phytolacca Decandra 4X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X.

Purpose:

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

**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.

Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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 spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

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

Inactive Ingredients:

Demineralized water, 20% Ethanol, Glycerin.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT SPRAY

2 fl. oz. (60 ml)

* Please review the disclaimer below.