Cepacol Extra Strength Sore Throat and Cough

The listing

NDC product code

63824-744 (labeller 63824, product 744)

Labeller

Reckitt Benckiser LLC

Brand name

Cepacol Extra Strength Sore Throat and Cough

Generic name

BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE

Dosage form

Lozenge

Route

oral

Marketing category

OTC MONOGRAPH DRUG M012

Marketing start

5 May 2014

Listing expires

31 December 2027

Pharmacologic class

Standardized Chemical Allergen [EPC]

RxNorm concept

1039251

Active ingredients

Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.

What the label claims

These are read from this product's own label, not assigned by us and not inferred from the ingredient.

Stated purposeCough suppressantOral anesthetic

Stated useSore throatCoughSore mouth, gums and canker soresCommon cold symptoms

Drug Facts, as filed

Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.

Active ingredient

(in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant

Purpose

Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant

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

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...

Ask a doctor before use

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 if

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

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

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.

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

Inactive ingredients

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

Storage

Other information store at 20-25°C (68-77°F) protect contents from humidity

Other information

1-866-682-4639

Label version 14, effective 13 May 2026. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.

Identical on the active ingredient

6 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 6 different labellers. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.

Sources for this page

• FDA National Drug Code Directory entry for 63824-744
• DailyMed label, set id c0cc32db-90f0-4106-8538-89821083ece1
• How Lozenges builds these pages