Cepacol Extra Strength Sore Throat and Cough

Cepacol Extra Strength Sore Throat and Cough is an FDA-registered drug product whose active ingredient is BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63824-744, application M012, label effective 20260513. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, common cold, pain associated, canker sores, sore mouth. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cepacol Extra Strength Sore Throat and Cough used for?
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

Who makes Cepacol Extra Strength Sore Throat and Cough?
Reckitt Benckiser LLC is the labeler of record for Cepacol Extra Strength Sore Throat and Cough.

What form does Cepacol Extra Strength Sore Throat and Cough come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cepacol Extra Strength Sore Throat and Cough prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Cepacol Extra Strength Sore Throat and Cough been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.