HALLS SPEARMINT (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]

HALLS SPEARMINT (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]
PDF | XML

NDC 12546-332-09
Set ID 59d6f1f7-9df0-4565-a1aa-21beb070468f
Category HUMAN OTC DRUG LABEL
Packager Mondelēz Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    <(per drop) Menthol 5.4 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

    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

    • 15 calories per drop
    • Contains:  SOY.
  • Inactive ingredients

    <beta carotene, eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, sucrose, water>

  • 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

    <NDC 12546-332-09 Halls Spearmint 9ct stick>MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  SPEARMINT
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-332
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (light green) Scoreno score
    ShapeSQUARESize21mm
    FlavorSPEARMINT (Spearmint) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-332-0909 in 1 PACKAGE; Type 0: Not a Combination Product12/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/12/2016
    Labeler - Mondelēz Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-332)

Related Drugs