MUCINEX INSTA SOOTHE SORE THROAT WINTER FRESH- benzocaine and menthol, unspecified form spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzocaine 5%, Menthol 2%

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Pain Reliever temporarily relieves occasional minor irritation and pain associated with ■ sore throat ■ sore mouth ■ canker sores

Authorization status:

OTC monograph not final

Summary of Product characteristics

MUCINEX INSTA SOOTHE SORE THROAT WINTER FRESH- BENZOCAINE AND
MENTHOL, UNSPECIFIED FORM SPRAY
RB HEALTH (US) LLC
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MUCINEX® INSTASOOTHE™ SORE THROAT WINTER FRESH
DRUG FACTS
ACTIVE INGREDIENTS
Benzocaine 5%
Menthol 2%
PURPOSE
Oral Pain Reliever
USES
temporarily relieves occasional minor irritation and pain associated
with
■ sore throat
■ sore mouth
■ canker sores
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.
DIRECTIONS
Adults and children 6 years of age and older:
apply to affected area (one spray); gargle, swish around in the mouth,
or allow to
remain in place at least 1 minute then spit out. Use up to 4 times
daily or as directed
by a doctor or dentist. Children 6 to under 12 years of age SUPERVISE
USE
Children un