Otc - Active Ingredient
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
Good Sense Cherry Benzocaine Lozenges Lozenge
FDA Label NDC 50804-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin, Dunn for the product Good Sense Cherry Benzocaine Lozenges (NDC 50804-025). 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 - do not use, 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
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 colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Sore throat warning: If sore throat is severe, persists 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.
Otc - Do Not Use
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.
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 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 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 - do not use
Other Safety Information
Other information
- store at room temperature
- protect from moisture
Inactive Ingredient
Inactive ingredients: Corn starch, corn syrup, FD&C Red #40, glycerin, medium chain triglycerides, artificial flavor, propylene glycol, soybean oil, sucrose and water.
Otc - Questions
Questions? Call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST
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