Label: JAKEMANS THROAT AND CHEST ANISE- menthol lozenge

  • NDC Code(s): 42637-827-01, 42637-827-02
  • Packager: Jakemans (Confectioners) Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 29, 2018

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient (in each lozenge)...Purpose

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


    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.

  • ASK DOCTOR

    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).
  • INDICATIONS & USAGE

    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.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    anise oil (flavoring), caramel color, eucalyptus oil (flavoring), glucose syrup, natural flavor, sugar, water.

  • QUESTIONS

    Questions and Comments?

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

  • 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.
  • PRINCIPAL DISPLAY PANEL

    Image of Label JAKEMANS

    Boston ENGLAND

    EST 1907



    Throat and Chest



    Anise 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 ANISE 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42637-827
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANISE OIL (UNII: 6Y89129C8H)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CARAMEL (UNII: T9D99G2B1R)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblack (Caramel (black)) Scoreno score
    ShapeOVAL (Lozenge) Size30mm
    FlavorANISE (Anise Flavoring) Imprint Code ol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42637-827-0124 in 1 BOX; Type 0: Not a Combination Product07/13/2011
    2NDC:42637-827-0230 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)