Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton NDC 63824-744-16 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 flavor *based on amount of benzocaine per adult dose Label label 2
- PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton NDC 63824-744-16 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 flavor *based on amount of benzocaine per adult dose Label label 2
Overview
Uses Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat
Indications & Usage
Uses Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat
Dosage & Administration
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 as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist children under 6 years of age do not use
Warnings & Precautions
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 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. for teething in children under 6 years of age 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) 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 condition. 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.
Purpose
Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant
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. for teething in children under 6 years of age
Stop Use & Ask a Doctor
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 condition.
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information store at 20-25°C (68-77°F) protect contents from humidity
Questions
Questions? 1-866-682-4639
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