Label: CEPACOL  SORE THROAT- benzocaine and menthol lozenge 

  • NDC Code(s): 63824-712-16, 63824-712-94, 63824-712-98
  • Packager: Reckitt Benckiser LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

    temporary relief of occasional

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

    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.

    Do not use in a child 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 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.

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  • Directions

    • adults and children 5 years or older: allow 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
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  • Other information

    • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
    • store at room temperature 20-25°C (68-77°F)
    • protect contents from humidity
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  • Inactive ingredients

    D&C Red #33, FD&C Red #40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

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  • Questions?

    Call 1-888-963-3382

    You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

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

    Made in England

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  • PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

    NDC 63824-712-16

    NEW FORMULA!

    CÄ“pacol®

    SORE THROAT

    Benzocaine 15 mg | Menthol 3.6 mg
    Oral Pain Reliever

    • Instant Acting
    • Maximum Strength Numbing

    16 Lozenges
    cherry

    Principal Display Panel - 16 Lozenge Carton
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  • INGREDIENTS AND APPEARANCE
    CEPACOL   SORE THROAT
    benzocaine and menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-712
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 15 mg
    Menthol (Menthol) Menthol 3.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C red no. 33  
    FD&C red no. 40  
    isomalt  
    maltitol  
    propylene glycol  
    water  
    sodium bicarbonate  
    sucralose  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 18mm
    Flavor CHERRY Imprint Code S
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-712-16 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:63824-712-98 72 in 1 CARTON
    2 8 in 1 BLISTER PACK
    3 NDC:63824-712-94 1 in 1 CARTON
    3 4 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 03/15/2013
    Labeler - Reckitt Benckiser LLC (094405024)
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