Label: HALLS NATURALS HONEY LEMON CHAMOMILE- menthol lozenge

  • 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 August 7, 2013

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  • Active Ingredient

    <(in each drop) Menthol 2.5 mg>

  • Purposes

    <Cough Suppressant, Oral Anesthetic>

  • Uses

    <temporarily relieves:

    • cough due to a cold
    • occasional minor irritation or sore throat>
  • Warnings

    <Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.>

  • Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by 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.  These could be signs of a serious condition.
    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • Keep out of reach of children

  • Directions

    • adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other

    • 15 calories per drop
  • Inactive ingredients

    <citric acid, flavors, ginger, glucose syrup, honey, lemon grass, sage, soy lecithin, sucrose, tea extract, water, white thyme>

  • Questions

    <Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern time or visit our website at www.gethalls.com>

  • OTC Principal display panel

    image descriptionMM1

  • INGREDIENTS AND APPEARANCE
    HALLS NATURALS  HONEY LEMON CHAMOMILE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-224
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GINGER (UNII: C5529G5JPQ)  
    HONEY (UNII: Y9H1V576FH)  
    SAGE (UNII: 065C5D077J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeOVALSize21mm
    FlavorHONEY (Honey Lemon Chamomile) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-224-2525 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/07/2013
    Labeler - Mondelez Global LLC (050964956)
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