HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-640-25, 12546-640-70
Set ID 54e0d57e-1f48-45e2-86b3-0e50775996f4
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    <(per drop) Menthol 5.8 mg>

  • Purposes

    <Cough Suppressant, Oral Anesthetic>

  • Uses

    <temporarily relieves:

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

    <Sore throat warnings:  if sore throat is severe, persist 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.

    Enter section text here

  • Directions

    • adults and children 5 years and over:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed.
    • children under 5 years:  ask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 2 mg per drop
    • excessive consumption may have a laxative effect
    • 5 calories per drop
    • contains:  SOY.
  • Inactive ingredients

    <acesulfame potassium, aspartame, eucalyptus oil, FDC Blue 1, FDC Red 40, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

  • Questions?

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

  • OTC Principal Display Panel

    <NDC 12546-640-25 Halls SF Mountain Menthol 25 ct bag>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE MOUNTAIN MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-640
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOMALT (UNII: S870P55O2W)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize21mm
    FlavorMENTHOL (MOUNTAIN MENTHOL) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-640-2525 in 1 BAG; Type 0: Not a Combination Product06/03/2019
    2NDC:12546-640-7070 in 1 BAG; Type 0: Not a Combination Product06/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/03/2019
    Labeler - Mondelez Global LLC (050964956)

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