Cepacol Extra Strength Sore Throat cherry

Cepacol Extra Strength Sore Throat cherry is an FDA-registered drug product whose active ingredient is BENZOCAINE AND MENTHOL. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63824-713, application M022, label effective 20260512. It is one of 5 FDA drug label records sharing the active ingredient BENZOCAINE AND MENTHOL. 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 MENTHOL are most often described in connection with: temporarily relieves, occasional minor, pain associated, sore throat, mouth canker. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses USES temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores

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

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.

FDA lists 5 drug label records with BENZOCAINE AND MENTHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

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 cherry used for?
Uses USES temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores

Who makes Cepacol Extra Strength Sore Throat cherry?
Reckitt Benckiser LLC is the labeler of record for Cepacol Extra Strength Sore Throat cherry. 5 FDA label records share the active ingredient BENZOCAINE AND MENTHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cepacol Extra Strength Sore Throat cherry 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 cherry 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.

Are there other products containing BENZOCAINE AND MENTHOL?
Yes. 5 FDA drug label records list BENZOCAINE AND MENTHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cepacol Extra Strength Sore Throat cherry 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.