Therastat Lozenge
FDA Label NDC 50332-0137

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Therastat (NDC 50332-0137). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each lozenge)

Menthol 5.8 mg

Otc - Purpose

Purpose

Cough suppressant/oral anesthetic

Indications & Usage

Uses

Temporarily relieves sore throat and cough occurring with a cold

Warnings

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away

Dosage & Administration

Directions

Do not take more than directed

Adults and children 12 years of age and over:

  • allow one lozenge to dissolve slowly in mouth
  • may be repeated every 2 hours as needed or as directed by a doctor

    • Children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive ingredients 

corn starch, corn syrup, eucalyptus oil, FD&C red no. 40, glycerin, medium chain triglycerides, natural & artificial flavors, soybean oil, sucrose, water

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