BENZOCAINE and Menthol, Unspecified Form
BENZOCAINE and Menthol, Unspecified Form is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Mucinex Insta soothe Sore Throat Winter Fresh, MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF. Available dosage form: spray.
Drug Details
- Generic Name
- BENZOCAINE and Menthol, Unspecified Form
- Brand Names
- Mucinex Insta soothe Sore Throat Winter Fresh, MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF
- Application Number
- M012
- Sponsor
- Reckitt Benckiser LLC
- NDC Codes
- 2
- Dosage Forms
- SPRAY
- Routes
- ORAL
- Active Ingredients
- BENZOCAINE, MENTHOL, UNSPECIFIED FORM
Indications and Usage
Uses temporarily relieves occasional minor irritation and pain associated with sore throat sore mouth canker sores
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 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. 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. Do not use for teething in children under 6 years of age When using this product do not exceed recommended dosage Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.