FDA Label for Cepacol Extra Strength Sore Throat And Cough

Other

Drug Facts

Do not exceed recommended dosage.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

Otc - Purpose

Uses

temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common cold
• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 any 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, nausea, or vomiting, consult a doctor promptly.

Otc - Do Not Use

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

Otc - Stop Use

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 develops
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
• children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
• children under 6 years of age: do not use

Other Information

• store between 20-25°C (68-77°F)
• protect contents from humidity

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

Call 1-866-682-4639

You may also report side effects to this phone number.

Principal Display Panel - 16 Lozenge Blister Pack Carton

NDC 63824-744-16

READ ALL INFORMATION

TAKE
EVERY
4
hours

Cēpacol_®
EXTRA STRENGTH*

#1
DOCTOR
RECOMMENDED^†

SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

• Relieves Sore Throat Pain
• Quiets Cough    • Fast Acting
• Maximum Numbing

16 Lozenges mixed berry

*based on amount of benzocaine per adult dose.

Principal Display Panel - 16 Lozenge Blister Pack Carton - cepacol 01