Otc - Active Ingredient
Active Ingredients (in each lozenge)
Benzocaine 15mg
Menthol 3.6mg
Cherry Sore Throat Lozenges Lozenge
FDA Label NDC 41250-068
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Cherry Sore Throat Lozenges (NDC 41250-068). 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, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Pain Reliever
Indications & Usage
Uses - temporarily relieves these symptoms
occasional minor irritation, pain, sore mouth and sore throat
pain associated with cankor sores
Warnings
Warnings
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and 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.
Otc - Stop Use
Stop use and ask a doctor if
sore throat is severe or irritation, pain or redness persists or worsens
sore mouth symptoms do not improve is 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children 5 years and older: allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor
children under 5 years of age: ask a doctor
Inactive Ingredient
Inactive Ingredients
Corn starch, FD&C red #40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose, and water
Storage And Handling
store at room temperature
protect from moisture
Otc - Questions
Questions? Call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST
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