Otc - Active Ingredient
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 2.6 mg
Honey Lemon Sore Throat Lozenges Lozenge
FDA Label NDC 59779-644
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Honey Lemon Sore Throat Lozenges (NDC 59779-644). 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, other safety information, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral anesthetic
Indications & Usage
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
Warnings
Warnings
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or give to children under 5 years of age unless directed by a doctor.
Other Safety Information
Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Otc - Stop Use
Stop use and ask doctor if
sore throat is severe or irritation, pain or redness persists or worsens
sore mouth symptoms do not improve in 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.
children under 5 years - ask a doctor
Inactive Ingredient
Inactive ingredients: Corn starch, FD&C yellow no. 5 (tartrazine), glucose syrup, glycerin, honey, medium chaon triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM to 4PM EST
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