Label: KIDS THROAT- aconite 30c, belladonna 30c, chamomilla 30c, phytolacca 30c 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 May 1, 2014

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  • INACTIVE INGREDIENT

    Non-Active Ingredients

    Isomalt, Natural Pine-Lime

    Flavour, Natural colour (Turmeric)

  • ACTIVE INGREDIENT

    Each Lozenge Contains

    Aconite 30C

    Belladonna 30C

    Chamomilla 30C

    Phytolacca 30C

    in equal quantities


  • PURPOSE

    Indications

    For natural, temporary relief of pain

    and discomfort associated with inflamed sore throats, gums

    and ears.

  • WARNINGS

    Warnings: 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 reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Suck one Kids throat lozenge at the

    first sign of throat pain or discomfort.

    There is no need to finish the whole

    lozenge as the therapeutic benefit of the medicine

    will be gained in the first few licks or sucks.

    The recommended dose is 3 lozenges

    per day. Not to be used by children under 2 years

    of age without medical advice or supervision.

  • INDICATIONS & USAGE

    Indications

    For natural, temporary relief of pain or discomfort

    associated with inflamed sore throats, gums and

    ears. If symptoms persists, consult a

    healthcare professional.

  • STORAGE AND HANDLING

    STORE BELOW 30 C

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS THROAT  
    aconite 30c, belladonna 30c, chamomilla 30c, phytolacca 30c lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64997-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_X]
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_X]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeROUNDSize31mm
    FlavorLIME (Pine-Lime) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-100-0110 in 1 BOX
    2NDC:64997-100-0210 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    Labeler - KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES (751652405)
    Establishment
    NameAddressID/FEIBusiness Operations
    KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES751652405manufacture(64997-100)
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