Label: KIDS COUGH- drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozenge

  • Category: HUMAN OTC DRUG LABEL

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 orange Oil,

    Natural Colour E160C

  • ACTIVE INGREDIENT

    Each lozenge contains:

    Drosera 30C, Spongia 30C,

    Kali Carbonicum 30C,

    Phospherous 30C, Ipeacacuanha 30C,

    Pulsatilla 30C, Belladonna 30C

    in equal quantities


  • PURPOSE

    Indications

    For natural, temporary relief of

    cough and sore throat symptoms

    (hoarseness and dry cough)

  • WARNINGS

    Warning: If symptoms persist or worsen suddenly, consult your

    healthcare specialist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all other medicines out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    For best results, begin taking one

    KidsCough at the first sign of a cough or sore throat.

    Suck KidsCough and avoid chewing as it reduces

    absorption of active ingredients. Recommended dosage

    3 per day. Use only when symptoms exist. Not to be used

    in children under 2 years of age without medical advice.

  • INDICATIONS & USAGE

    Indications

    For natural, temporary relief of

    cough and sore throat symptoms

    (hoarseness and dry cough). If

    coughing persists, consult a healthcare professional.

  • STORAGE AND HANDLING

    STORE BELOW 30 C

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH  
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64997-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA INTERMEDIA (UNII: B3G4A96QLY) (DROSERA INTERMEDIA - UNII:B3G4A96QLY) DROSERA INTERMEDIA30 [hp_X]
    SPONGIA OFFICINALIS WHOLE (UNII: 755U7L3M7Z) (SPONGIA OFFICINALIS WHOLE - UNII:755U7L3M7Z) SPONGIA OFFICINALIS WHOLE30 [hp_X]
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Colorgreen (green) Scoreno score
    ShapeROUNDSize31mm
    FlavorAPPLE (apple) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-152-0110 in 1 BOX
    2NDC:64997-152-0210 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(64997-152)
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