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

HALLS SUGAR FREE EXTRA STRONG MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-313-02, 12546-313-25
Set ID 39005e21-80c7-4676-97b4-b545ceb17026
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredient

    <(per drop) 15 mg>

  • Purpose

    <Oral Anesthetic>

  • Uses

    <temporarily relieves occasional minor irritation and pain associated with

    • sore throat
    • sore mouth>
  • Warnings

    <Sore throat warning: 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.>

  • Stop Use and Ask a Doctor if

    • 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 1 drop slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other Information

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

    <acesulfame potassium, aspartame, citric acid, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

  • Questons

    <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 12546-313-25 Halls SF Extra Strong Menthol Flavor 25ct bag>iMM1

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE EXTRA STRONG MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-313
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOMALT (UNII: S870P55O2W)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (with blue specks) Scoreno score
    ShapeOVALSize21mm
    FlavorMENTHOL (Sugar Free Extra Strong Menthol) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-313-2525 in 1 BAG; Type 0: Not a Combination Product09/12/2016
    2NDC:12546-313-0202 in 1 PACKAGE; Type 0: Not a Combination Product09/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/12/2016
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-313)

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