Formula 3 Cough Syrup Liquid
FDA Label NDC 64616-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitality Works, Inc. for the product Formula 3 Cough Syrup (NDC 64616-072). 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 formula 3 cough syrup, formula 3 cough formula, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Formula 3 Cough Syrup

Unckaloabo (Pelargonium sidoides) 1X

Wild Cherry Bark (Prunus serotina) 1X

European Elderberry (Sambucus nigra) 1X

Buckwheat Honey, Elderberry Extract, Citric Acid, USP Purified Water, Natural Mixed Berry and Raspberry Flavor, Potassium Sorbate, Stevia, Xanthan Gum

Do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may be a sign of a serious condition. 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold.

Umckaloabo - Cough Suppressant

Wild Cherry Bark - Cough Suppressant

European Elderberry - Cough Suppressant

Formula 3 Cough Formula

- Children 2 to 4 years of age:  1/2 teaspoon every 3 hours, or as needed.

- Children 5 to 11 years of age:  1 teaspoon every 3 hours, or as needed.

Children under 2 years of age:  Consult your healthcare practitioner

* Please review the disclaimer below.