Label: CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

  • NDC Code(s): 63824-713-04, 63824-713-16, 63824-713-94
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 8, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purposes
    Benzocaine 15 mgOral pain reliever
    Menthol 3.6 mgOral pain reliever
  • Uses

    For the temporary relief of occasional

    • sore throat
    • sore mouth
    • minor irritation
    • pain
    • pain associated with canker sores
  • 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.

  • 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
  • Other information

    • store at 20-25°C (68-77°F)
    • protect contents from humidity
  • Inactive ingredients

    D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

  • Questions?

    1-866-682-4639
    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

    NDC 63824-713-16
    READ ALL WARNINGS

    Cēpacol®
    EXTRA STRENGTH

    #1
    DOCTOR
    RECOMMENDED

    SORE THROAT
    Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers

    • Relieves Sore Throat Pain
    • Fast Acting
    • Maximum Numbing*

    16 Lozenges cherry
    *based on amount of benzocaine per dose

    PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    CEPACOL   EXTRA STRENGTH SORE THROAT CHERRY
    benzocaine and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-713
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine15 mg
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form3.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    isomalt (UNII: S870P55O2W)  
    maltitol (UNII: D65DG142WK)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize18mm
    FlavorCHERRYImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-713-162 in 1 CARTON07/15/2013
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63824-713-941 in 1 CARTON07/15/2013
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63824-713-041 in 1 CARTON07/15/2013
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/15/2013
    Labeler - RB Health (US) LLC (081049410)