Otc - Active Ingredient
Active ingredient (in each lozenge)
Menthol 7 mg
Therastat, Cherry
FDA Label NDC 50332-0147
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, Cherry (NDC 50332-0147). 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, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Other Safety Information
Other information
- Contains: SOY
- 12 calories per drop
- store at 59° to 86°F (15°-30°C) in a dry place
- avoid excessive heat and humidity
Inactive Ingredient
Inactive ingredients
corn syrup, eucalyptus oil, FD&C red #40, natural & artificial flavors, soy lecithin, sucrose, water
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