Label: CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH- benzocaine and dextromethorphan hydrobromide lozenge

  • NDC Code(s): 63824-744-16, 63824-744-36, 63824-744-94
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2025

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • ACTIVE INGREDIENT
    Active ingredients (in each lozenge)Purposes - Benzocaine 7.5 mgOral pain reliever - Dextromethorphan HBr 5 mgCough 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 ...
  • 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 ...
  • Directions
    adults and children 12 years of age and oldertake 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 ...
  • Other information
    store at 20-25°C (68-77°F) protect contents from humidity
  • Inactive ingredients
    FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose
  • Questions?
    1-866-682-4639
  • SPL UNCLASSIFIED SECTION
    Dist. by: RB Health (US) Parsippany, NJ 07054-0224
  • 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information