KIDS COUGH (DROSERA 30C, SPONGIA 30C, KALI CARBONICUM 30C, PHOSPHEROUS 30C, IPECACUHUANA 30C, PULSATILLA 30C, BELLADONNA 30C) KIT [KEYSUN PTY. LIMITED ALSO TRADED AS KEYSUN LABORATORIES]

KIDS COUGH (DROSERA 30C, SPONGIA 30C, KALI CARBONICUM 30C, PHOSPHEROUS 30C, IPECACUHUANA 30C, PULSATILLA 30C, BELLADONNA 30C) KIT [KEYSUN PTY. LIMITED ALSO TRADED AS KEYSUN LABORATORIES]
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NDC 64997-150-01, 64997-152-01, 64997-180-01, 64997-300-01
Set ID a8bc1713-b6ee-4231-bcf8-bdf483c1c076
Category HUMAN OTC DRUG LABEL
Packager KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES
Generic Name
Product Class
Product Number
Application Number
  • INACTIVE INGREDIENT

    Non-Active Ingredients

    Non-active ingredients for kids cough apple:

    Isomalt, Natural Apple Flavour, Natural

    Colours, Carokram and Vegetable (Blue Gardinea)

    Non-active ingredients for kids cough orange:

    Isomalt, Natural Orange and Colour (Annato),

    Non-active ingredients for kids cough raspberry:

    Isomalt, Natural Raspberry Flavour and Natural

    Colour Carmine (Cochineal)

  • ACTIVE INGREDIENT

    Active Ingredients for kids cough apple:

    Each lozenge contains:

    Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

    Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

    Belladonna 30C

    in equal quantities.

    Active Ingredients for kids cough orange:

    Each lozenge contains:

    Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

    Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

    Belladonna 30C

    in equal quantities.

    Active Ingredients for kids cough raspberry:

    Each lozenge contains:

    Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

    Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

    Belladonna 30C

    in equal quantities


  • PURPOSE

    Indications

    Indications for kids cough apple:

    For natural, temporary relief of cough and

    sore throat symptoms (hoarseness and dry cough).

    Indications for kids cough orange:

    For natural, temporary relief of cough and

    sore throat symptoms (hoarseness and dry cough).

    Indications for kids cough raspberry:

    For natural, temporary relief of cough and

    sore throat symptoms (hoarseness and dry cough).

  • WARNINGS

    Warning:

    Warning for kids cough apple:

    If symptoms persist or suddenly worsen, consult your

    healthcare specialist.

    Warning for kids cough orange:

    If symptoms persist or suddenly worsen, consult your

    healthcare specialist.

    Warning for kids cough raspberry:

    If symptoms persist or suddenly worsen, consult your

    healthcare specialist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children for kids cough apple:

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

    Keep Out of Reach of Children for kids cough orange:

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

    Keep Out of Reach of Children for kids cough raspberry:

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

  • DOSAGE & ADMINISTRATION

    Directions

    Directions for kids cough apple:

    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.

    Directions for kids cough orange:

    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.

    Directions for kids cough raspberry:

    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 kids cough apple:

    For natural, temporary relief of cough

    and sore throat symptoms (hoarseness and

    dry cough). If coughing persists,

    consult a heathcare professional.

    Indications for kids cough orange:

    For natural, temporary relief of cough

    and sore throat symptoms (hoarseness and

    dry cough). If coughing persists,

    consult a healthcare professional.

    Indications for kids cough raspberry:

    For natural, temporary relief of cough

    and sore throat symptoms (hoarseness and

    dry cough). If coughing persists, consult a

    healthcare professional.

  • STORAGE AND HANDLING

    Storage and Handling for kids cough apple:

    STORE BELOW 30 C

    Storage and Handling for kids cough orange:

    STORE BELOW 30 C

    Storage and Handling for kids cough raspberry:

    STORE BELOW 30 C


  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH  
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipecacuhuana 30c, pulsatilla 30c, belladonna 30c kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64997-300
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-300-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 KIT
    Part 21 KIT
    Part 31 KIT
    Part 1 of 3
    KIDS COUGH  
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozenge
    Product Information
    Item 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:64997-152-014 in 1 KIT
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    Part 2 of 3
    KIDS COUGH  
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozenge
    Product Information
    Item Code (Source)NDC:64997-150
    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
    Colororange (orange) Scoreno score
    ShapeROUNDSize31mm
    FlavorORANGE (orange) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-150-014 in 1 KIT
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    Part 3 of 3
    KIDS COUGH  
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozenge
    Product Information
    Item Code (Source)NDC:64997-180
    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)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUNDSize31mm
    FlavorRASPBERRY (raspberry) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-180-014 in 1 KIT
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    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(64997-300)

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