FDA Label for Cherry Sore Throat Lozenze
View Indications, Usage & Precautions
Cherry Sore Throat Lozenze Product Label
The following document was submitted to the FDA by the labeler of this product Geiss, Destin & Dunn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
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
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.
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.
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 - ask a doctor
Inactive Ingredient
Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup, glycerin, medium chain triglycerides, natural and srtificial flavors, propylene glycol, soybean oil, sucrose and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9am to 4pm EST
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