Otc - Active Ingredient
Active ingredient (in each lezenge)
Benzocaine 15 mg
Menthol 3.6 mg
Cherry Sore Throat Lozenge
FDA Label NDC 59779-545
14 label sections · Submitted to the FDA by Cvs Pharmacy · 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 Cherry Sore Throat Lozenge (NDC 59779-545). 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 - do not use, otc - stop use, otc - pregnancy or breast feeding, 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
Oral anesthetic
Indications & Usage
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
Warnings
Warnings
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue of lack of energy
Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
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 - Do Not Use
Do not use
- for teething
- in children under 2 years of age
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 of 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 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 2 hours as necessary or a directed by a doctor.
children under 5 years - do not use
Inactive Ingredient
Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
Otc - Questions
Questions? Call 1-800-245-2898 Monday - Friday, 9AM to 4PM EST
Package Label.Principal Display Panel
Cvs Cherry Benzocaine 18ct (Cvs Cherry Benzocaine 18ct 1)
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