Uses
temporary relief of occasional
- sore throat
- sore mouth
- minor mouth irritation
- pain associated with canker sores
Sore Throat Logenzes Lozenge
FDA Label NDC 0904-6255
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Sore Throat Logenzes (NDC 0904-6255). 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 uses, allergy alert, sore throat warning, directions, other information, inactive ingredients, questions?, principal display panel- 16 lozenge carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Allergy Alert
- Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.
Sore Throat Warning
- If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.
Directions
- adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
- children under 5 years of age: ask a doctor
Other Information
- tamper evident packaging: Do not use if outer box or blister is open or damaged.
- store at room temperature
- protect contents from moisture
Inactive Ingredients
Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.
Questions?
Call 1-800-616-2471
Principal Display Panel- 16 Lozenge Carton
NDC 0904-6255-49
MAJOR SORE THROAT LOZENGES
Fast, Long Lasting Relief
Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever
18 Lozenges
cherry
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