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FDA LABEL GENERIC: Benzocaine MFR: Reckitt Benckiser LLC

Cepacol Sore Throat 15 Mg / 3.6 Mg Oral Lozenge

Drug Facts

Active ingredients (in each lozenge) Purposes
Benzocaine 15 mg Oral pain reliever
Menthol 3.6 mg Oral pain reliever

Uses

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 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, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

1-866-682-4639

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC 63824-713-16

Cēpacol ®
EXTRA STRENGTH

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SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers

Relieves Sore Throat Pain Fast Acting Maximum Numbing*

16 Lozenges cherry flavor
*based on amount of benzocaine per dose