Cough Tonic Liquid
FDA Label NDC 63083-2995

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Cough Tonic (NDC 63083-2995). 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, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Spongia tosta 2X
Aconitum napellus 3X
Belladonna 3X
Bryonia 3X
Pulsatilla 4X
Ipecacuanha 5X
Arsenicum album 6X
Drosera rotundifolia 6X

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

Temporarily reduces the intensity of coughing and congestion.*

Otc - Purpose

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

Warnings

A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place liquid under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one teaspoon up to 2 times per day. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

Glycyrrhiza glabra root extract (1:1), polygala tenuifolia root extract (1:1), grindelia camporum aerial parts extract (1:1), inula helenium root extract (1:1), thymus vulgaris leaves extract (1:1), verbascum thapsus leaves extract (1:2), asclepias tuberosa root extract (1:1), zingiber officinale root extract (1:1), pimpinella anisum seed extract (1:1), 15% vegetable glycerin (from soy), 10% ethanol, 5% cherry extract, purified water.

Label

Est 1985

Professional Formulas

Complementary Health

Cough Tonic

Homeopathic Remedy

4 FL. OZ. (118 mL)

Label Image (Cct Thumb)

Label Image (Cct Thumb)

* Please review the disclaimer below.