CHERRY THROAT RELIEF LOZENGES- benzocaine lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Cintas Corporation

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral anesthetic Oral anesthetic Uses temporarily relieves these symptoms: occasional minor irritation, pain, sore mouth and sore throat Do not use - for teething - in children under 2 years of age 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

CHERRY THROAT RELIEF LOZENGES- BENZOCAINE LOZENGE
CINTAS CORPORATION
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CHERRY LOZENGES
ACTIVE INGREDIENT (IN EACH LOZENGE)
Benzocaine 15 mg
Menthol 3.6 mg
_PURPOSE_
Oral anesthetic
Oral anesthetic
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
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 if breath
dizziness or lightheadedness
fatigue or lack of energy
SORE THROAT WARNING: if sore throat is severe, persist for more than 2
days, is
accompanied or followed by fever, headache, rash, swelling, nausea, or
vomiting,
consult a doctor promptly. If sore mouth symptoms do not improve in 7
days, or if
irritation, pain, or redness persist or worsens, see your dentist or
doctor promptly.
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.
store at room temperature
protect from moisture
DO NOT USE
for teething
in children under 2 years of age
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
If pregnant of breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact
Poison Control Center right away.
Directions
adults and children 5 years and older - allow 1 lozenge to dissolve
slowly in mouth. May
be repeated every 2 hours as necessary or as directed by a doctor.
children under 5 years - do not use
Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup,
glycerin, medium
chain triglycerides, natural and artificia