Label: CEPACOL SORE THROAT FROM POST NASAL DRIP- menthol lozenge 

  • 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 12/09

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

  •      

    Cēpacol® Sore Throat from Post Nasal Drip Cherry Lozenges

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  • Active Ingredients (in each lozenge)

    Menthol 4.5 mg                              

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  • Purpose

    Oral analgesic

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  • Uses

    temporarily relieves occasional:

    • sore throat pain
    • sore mouth
    • minor mouth irritation
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  • Warnings

    Sore Throat Warning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

    Stop use and ask a doctor if

    sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

    If pregnant or breast feeding

    ask a health professional before use.

    Keep this and all drugs 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.

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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   

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

    cetylpyridinium chloride (Ceepryn®), flavor, glucose, propylene glycol, red 33, red 40, sucrose

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  • Principal Display Panel

    COOLING VAPOR RELIEF

    Cēpacol®

    Sore Throat

    from Post Nasal Drip

    Menthol Oral Analgesic Lozenges

    Works Instantly

    #1 in Hospitals*

    CHERRY

    18 Lozenges

    Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    CEPACOL SORE THROAT FROM POST NASAL DRIP 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11509-0003
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 4.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CETYLPYRIDINIUM CHLORIDE  
    ANHYDROUS DEXTROSE  
    ACESULFAME POTASSIUM  
    PROPYLENE GLYCOL  
    D&C RED NO. 33  
    SUCROSE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 18mm
    Flavor CHERRY Imprint Code C
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11509-0003-1 2 in 1 CARTON
    1 9 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 07/28/2003
    Labeler - Combe Incorporated (002406502)
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