Coughtone Liquid
FDA Label NDC 44911-0593

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 Coughtone (NDC 44911-0593). 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:, directions:, inactive ingredients:, keep out of reach of children:, 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): 14.26% of Antimonium Tartaricum 12X, Aralia Racemosa 12X, Drosera (Rotundifolia) 12X, Ipecacuanha 12X, Kali Carbonicum 12X, Phosphorus 12X, Spongia Tosta 12X; 0.10% of Echinacea (Angustifolia) 3X, Lobelia Inflata 3X.

Indications:

May temporarily relieve tickling, short, dry cough, barking cough, very deep cough and hoarseness.**

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

May temporarily relieve tickling, short, dry cough, barking cough, very deep cough and hoarseness.**

**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.

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.

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

COUGHTONE

1 fl. oz. (30 ml)

* Please review the disclaimer below.