JAKEMANS THROAT AND CHEST PEPPERMINT (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LTD.]

JAKEMANS THROAT AND CHEST PEPPERMINT (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LTD.]
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NDC 42637-824-01, 42637-824-02
Set ID 6d5fe101-2e06-2208-e053-2a91aa0a2202
Category HUMAN OTC DRUG LABEL
Packager Jakemans (Confectioners) Ltd.
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient (in each lozenge)                                Purpose

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

  • PURPOSE

    JAKEMANS® Boston ENGLAND Est 1907

    Throat & Chest™ Peppermint Flavored Menthol Cough Suppressant Oral Anesthetic

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

    30 Lozenges

    Jakemans famous and original Throat & Chest Lozenges are made with the finest natural ingredients, carefully blended with soothing menthol to obtain a unique mouth watering and refreshing taste. Once tasted they will be your favorite soothing lozenge!

    Manufactured by:

    Jakemans (Confectioners) Ltd.

    Boston PE20 2JA, United Kingdom

    US Toll Free: 1-866-205-1185

    www.jakemans.us

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    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.
  • 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.

    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 more 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.

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

  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive Ingredients glucose syrup, peppermint oil (flavoring), sugar, water.

  • OTHER SAFETY INFORMATION

    Questions & Comments?

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

    No added color

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    JAKEMANS THROAT AND CHEST PEPPERMINT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42637-824
    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)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize30mm
    FlavorPEPPERMINTImprint Code ol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42637-824-0130 in 1 PACKAGE; Type 0: Not a Combination Product12/11/2013
    2NDC:42637-824-0224 in 1 PACKAGE; Type 0: Not a Combination Product12/11/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/11/2013
    Labeler - Jakemans (Confectioners) Ltd. (218806669)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jakemans (Confectioners) Ltd.218806669manufacture(42637-824) , relabel(42637-824) , repack(42637-824)

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