Label: KIDS TRAVEL SICKNESS- cocculus 30c, nux vomica 30c, borax 6c lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 12, 2014

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  • INACTIVE INGREDIENT

    Non-Active Ingredients

    Isomalt, Natural Strawberry Flavour,

    Natural Colour Carmine E120 (Cochineal).

  • ACTIVE INGREDIENT

    Each Lozenge Contains

    Cocculus 30C, Nux Vomica 30C,

    Borax 6C in equal quantities

  • PURPOSE

    Indications

    For natural temporary relief of

    motion sickness and nausea

  • WARNINGS

    Warning: If symptoms persist or worsen suddenly, consult your health-care

    specialist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all other medicine out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    For best results, begin taking one Kids Travel Sickness

    15-20 minutes before travel. The lozenge should be licked

    or sucked and does not need to be finished as the

    therapeutic benefit will be gained in the first few licks.

    If on a long journey, suck another lozenge if needed. Not

    to be used in children under 2 years of age without medical advice.

    Recommended dosage up to 3 per day.

  • STORAGE AND HANDLING

    STORE BELOW 30 C

  • INDICATIONS & USAGE

    Indications

    For natural, temporary relief of motion sickness

    and nausea

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS TRAVEL SICKNESS 
    cocculus 30c, nux vomica 30c, borax 6c lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76509-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JATEORHIZA CALUMBA ROOT (UNII: V36I2B8LD5) (JATEORHIZA CALUMBA ROOT - UNII:V36I2B8LD5) JATEORHIZA CALUMBA ROOT30 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Colororange (orange) Scoreno score
    ShapeROUNDSize31mm
    FlavorSTRAWBERRY (Strawberry) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76509-050-0110 in 1 BOX
    2NDC:76509-050-0210 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/11/2014
    Labeler - Natures Investment Holdings Pty Ltd dba Maxrelief USA (745559703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Investment Holdings Pty Ltd dba Maxrelief USA745559703manufacture(76509-050)
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