Label: THROAT AND CHEST HONEY LEMON AND MENTHOL- menthol lozenge

  • NDC Code(s): 42637-813-01, 42637-813-02
  • 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 02/13

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  • PRINCIPAL DISPLAY PANEL

    Image of Label
    JAKEMANS
    Boston ENGLAND
    EST 1907

    Throat and Chest

    Honey and Lemon Flavored
    With other Natural Flavor
    Menthol Cough Suppressant
    Oral Anesthetic

    Made in Boston, England, for over 100 years
    using the finest natural ingredients

    24 LOZENGES Close
  • ACTIVE INGREDIENT

    Drug Facts
    Active Ingredient (in each lozenge)...Purpose
    Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic Close
  • PURPOSE

    Uses Temporarily relieves
    • cough due to minor throat and brochial irritation occurring with the common cold or inhaled irritants.
    • occasional minor irritation, pain, sore mouth, and sore throat.
    Close
  • 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. Close
  • 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).

    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 mat be a sign of a serious condition.
    • sore mouth symptoms do not improve in 7 days.
    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding,ask a health professional before use. Close
  • 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.
    Close
  • QUESTIONS

    Questions and Comments?
    To report serious adverse enets, call: 1-866-205-1185 Close
  • INACTIVE INGREDIENT

    Inactive Ingredients beta carotene (coloring), glucose syrup, honey, lactic acid, lemon oil (flavoring), natural flavor), sodium lactate, sugar, water. Close
  • INGREDIENTS AND APPEARANCE
    THROAT AND CHEST HONEY LEMON AND MENTHOL 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42637-813
    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
    Honey  
    Lemon Oil  
    Beta Carotene  
    Lactic Acid  
    Water  
    Sucrose  
    CORN SYRUP  
    Product Characteristics
    Color yellow (Beta Carotene) Score no score
    Shape OVAL (Lozenge) Size 30mm
    Flavor HONEY (Natural flavor) , LEMON (Lemon Oil) Imprint Code ol
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42637-813-01 24 in 1 BOX
    2 NDC:42637-813-02 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)
    Close