JAKEMANS THROAT AND CHEST CHERRY (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]

JAKEMANS THROAT AND CHEST CHERRY (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]
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NDC 42637-825-01, 42637-825-02
Set ID 6d5f3330-c67b-ada6-e053-2991aa0a9bbd
Category HUMAN OTC DRUG LABEL
Packager Jakemans (Confectioners) Limited
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient (in each lozenge)...Purpose

    Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic

  • 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.

  • 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.

  • 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

    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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • 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.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    carmine (color), glucose syrup, lactic acid, natural flavor, sodium lactate, sugar, water.

  • QUESTIONS

    Questions and Comments?

    To report serious adverse enets, call: 1-866-205-1185

  • PRINCIPAL DISPLAY PANEL

    Image of Label JAKEMANS

    Boston ENGLAND

    EST 1907



    Throat and Chest



    Cherry 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

  • INGREDIENTS AND APPEARANCE
    JAKEMANS THROAT AND CHEST CHERRY 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42637-825
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorred (CARMINE) Scoreno score
    ShapeOVAL (Lozenge) Size30mm
    FlavorCHERRY (Natural Flavor) Imprint Code ol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42637-825-0124 in 1 BOX; Type 0: Not a Combination Product07/13/2011
    2NDC:42637-825-0230 in 1 BAG; Type 0: Not a Combination Product07/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/13/2011
    Labeler - Jakemans (Confectioners) Limited (218806669)

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