CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RB Health (US) LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

For the temporary relief of occasional - sore throat - sore mouth - minor irritation - pain - pain associated with canker sores

Authorization status:

OTC monograph not final

Summary of Product characteristics

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- BENZOCAINE AND
MENTHOL LOZENGE
RB HEALTH (US) LLC
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CĒPACOL
EXTRA STRENGTH SORE THROAT CHERRY
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH LOZENGE)_
_PURPOSES_
Benzocaine 15 mg
Oral pain reliever
Menthol 3.6 mg
Oral pain reliever
USES
For the temporary relief of occasional
sore throat
sore mouth
minor irritation
pain
pain associated with 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 5 years of age
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.
DO NOT EXCEED RECOMMENDED DOSAGE.
DIRECTIONS
adults and children 5 years of age and older: allow one 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 20-25°C (68-77°F)
protect contents from humidity
INACTIVE INGREDIENTS
D&C red no. 33, FD&C red no. 40,