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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purposes
    Benzocaine 15 mgOral pain reliever
    Menthol 2.6 mgOral pain reliever
  • Uses

    Temporary relief of occasional

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

    METHEMOGLOBINEMIA WARNING

    Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 any 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, nausea, or vomiting, consult a doctor promptly.

    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 this and all drugs out of the 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 between 20-25°C (68-77°F)
    • protect contents from humidity
  • Inactive ingredients

    D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

  • Questions?

    Call 1-866-682-4639

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224
    Made in England

  • CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE

    image description

  • INGREDIENTS AND APPEARANCE
    CEPACOL   EXTRA STRENGTH SORE THROAT HONEY LEMON
    benzocaine and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0732(NDC:63824-732)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    isomalt (UNII: S870P55O2W)  
    maltitol (UNII: D65DG142WK)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize18mm
    FlavorHONEY (Honey-Lemon) Imprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0732-150 in 1 BOX04/17/2024
    1NDC:17856-0732-21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM07/15/2013
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194REPACK(17856-0732)
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