Label: THROAT AND CHEST CHILI AND LIME- menthol lozenge 

  • Label RSS
  • NDC Code(s): 42637-820-01
  • Packager: Jakemans (Confectioners) Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 04/13

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

  • ACTIVE INGREDIENT

    Drug FactsActive Ingredient (in each lozenge)...Purposes
    Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic

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  • INDICATIONS & USAGE

    Ask a doctor before use if you have
    • persistent or chronic cough as occurs with smoking, asthma or emphysema.
    • cough that occurs with excessive phlegm (mucus).
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  • STOP USE

    Stop use and ask a doctor if

    • cough persists for man than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    • sore mouth symptoms do not improve in 7 days.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Close
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repear every 2 hours as needed or as directed by a doctor.
    • children under 2 years of age: ask a doctor.
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Glucose syrup, natural flavors, sugar, water.

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  • QUESTIONS

    Questions and Comments?To report serious adverse events, call: 1-866-205-1185

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  • PURPOSE

    Uses

    Temporarily relieves

    • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.
    • occasional minor irritation, pain, sore mouth, and sore throat.
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  • WARNINGS

    Warnings

    Sore throat warning

    If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • INGREDIENTS AND APPEARANCE
    THROAT AND CHEST CHILI AND LIME 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42637-820
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (MENTHOL) Menthol 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    CORN SYRUP  
    SUCROSE  
    Product Characteristics
    Color green Score no score
    Shape OVAL (Lozenge) Size 30mm
    Flavor LIME (Natural Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42637-820-01 30 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/13/2011
    Labeler - Jakemans (Confectioners) Limited (218806669)
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