BENZOCAINE and Menthol, Unspecified Form

FDA Drug Profile — Mucinex Insta soothe Sore Throat Winter Fresh, MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF

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
RB Health (US) LLC
NDC Codes
2
Dosage Forms
SPRAY
Routes
ORAL
Active Ingredients
BENZOCAINE, MENTHOL, UNSPECIFIED FORM

Indications and Usage

Uses for the temporary relief of pain associated with canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums.

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. Do not use for teething in children under 2 years of age When using this product do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. do not exceed recommended dosage. Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.