CEPACOL SORE THROAT MAXIMUM NUMBING CHERRY benzocaine and menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

Combe Incorporated

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 15 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

CEPACOL SORE THROAT MAXIMUM NUMBING CHERRY- BENZOCAINE AND
MENTHOL LOZENGE
CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY- BENZOCAINE AND
MENTHOL LOZENGE
CEPACOL SORE THROAT MAXIMUM NUMBING CITRUS- BENZOCAINE AND
MENTHOL LOZENGE
CEPACOL SORE THROAT MAXIMUM NUMBING HONEY LEMON- BENZOCAINE AND
MENTHOL LOZENGE
COMBE INCORPORATED
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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CEPACOL SORE THROAT MAXIMUM NUMBING
CĒPACOL® SORE THROAT MAXIMUM NUMBING CHERRY LOZENGES
_ACTIVE INGREDIENTS (IN EACH LOZENGE)_
Benzocaine 15.0 mg
_PURPOSE_
Oral anesthetic
_ACTIVE INGREDIENTS (IN EACH LOZENGE)_
Menthol 3.6 mg
_PURPOSE_
Oral analgesic
_USES_
temporarily relieves occasional:
sore throat pain
sore mouth
minor mouth irritation
pain associated with canker sores
_WARNINGS_
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: Severe or persistent sore throat or sore throat
accompanied by high fever,
headache, nausea, and vomiting may be serious. Consult a doctor
promptly. Do not use for more than 2
days or give to children under 5 years of age.
STOP USE AND ASK A DOCTOR IF
sore mouth symptoms do not improve in 7 days, or if irritation, pain
or redness persists or worsens.
IF PREGNANT OR BREAST FEEDING
ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
DO NOT EXCEED RECOMMENDED DOSAGE.
_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: do not use.
_OTHER INFORMATION _
store at room temperature (68-77°F) (20-25°C)
protect contents from humidity
_IN