Cough Drops

Cough Drops is an FDA drug label for the active ingredient MENTHOL manufactured by Topco Associates LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231103.

Generic: MENTHOL

Manufacturer: Topco Associates LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 76162-027

Application: M012

Effective: 20231103

Active Ingredients: Active ingredient 7.5 mg Cough Suppressant Oral anesthetic Front Panel

Indications & Usage

Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat

Dosage & Administration

Directions Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 12 years and under do not use

Contraindications

Not available.

Warnings

Warnings Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Adverse Reactions

Not available.

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