KIDS COUGH COLD AND THROAT (DROSERA 30C, SPONGIA 30C, KALI CARBONICUM 30C, PHOSPHEROUS 30C, IPEACACUHUANA 30C, PULSATILLA 30C, BELLADONNA 30C) KIT [KEYSUN PTY. LIMITED ALSO TRADED AS KEYSUN L

KIDS COUGH COLD AND THROAT (DROSERA 30C, SPONGIA 30C, KALI CARBONICUM 30C, PHOSPHEROUS 30C, IPEACACUHUANA 30C, PULSATILLA 30C, BELLADONNA 30C) KIT [KEYSUN PTY. LIMITED ALSO TRADED AS KEYSUN L
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NDC 64997-100-01, 64997-150-01, 64997-200-01, 64997-400-01
Set ID a8124d13-d8ea-4251-b537-dec77470595e
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 for Cough:

    Isomalt, Natural Orange Oil, Natural Colour E160C

    Non-Active Ingredients for Cold:

    Isomalt, Citric Acid, Flavours,

    Bixa Orellana (annatto) seed powder,

    turmeric, cabbage.

    Non-Active Ingredients for Throat:

    Isomalt, Natural Pine-Lime Flavour,

    Natural Colour, Turmeric.

  • ACTIVE INGREDIENT

    Active Ingredients

    Each Lozenge Contains for kids cough:

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

    Phospherous 30C, Ipeacacuanha 30C,

    Pulsatilla 30C, Belladonna 30C

    in equal quantities

    Each Lozenge Contains for kids cold:

    Alium Cepa 30C, Kali Bichromicum 30C,

    Kali Sulphuricum 30C, Nux Vomica 30C,

    Natrum Muriaticum 30C, Pulsatilla

    30C, Silcea 30C, in equal quantities.

    Each Lozenge contains for kids throat:

    Aconite 30C, Belladonna 30C, Chamomilla

    30C, Phytolacca 30C, in equal quantities.

  • PURPOSE

    Indications for kids cough:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.

    Indications for kids cold:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.

    Indications for kids throat:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.

  • WARNINGS

    Warning for kids cough:

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

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

    Warning for kids cold:

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

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

    Warning for kids throat:

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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children for kids cough:

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

    Keep Out of Reach of Children for kids cold:

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

    Keep Out of Reach of Children for kids throat:

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


  • DOSAGE & ADMINISTRATION

    Directions for kids cough:

    Suck one Kids lozenge at the first

    sign of 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.

    Directions for kids cold:

    Suck one Kids lozenge at the first

    sign of 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.

    Directions for kids throat:

    Suck one Kids lozenge at the first

    sign of 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 kids cough:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.

    Indications for kids cold:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.

    Indications for kids throat:

    For natural, temporary relief of pain and

    discomfort of Cough, Cold and Throat symptoms.


  • STORAGE AND HANDLING

    Storage for kids cough:

    STORE BELOW 30 C

    Storage for kids cold:

    STORE BELOW 30 C

    Storage for kids throat:

    STORE BELOW 30 C

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH COLD AND THROAT 
    drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64997-400
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-400-011 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:64997-150
    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 2 of 3
    KIDS COLD  
    allium cepa 30c, kali bichromium 30c, kali sulphuricum 30c, nux vomica 30c, natrum muriaticum 30c, pulsatilla 30c, silicea 30c lozenge
    Product Information
    Item Code (Source)NDC:64997-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION30 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]
    POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE30 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    TURMERIC (UNII: 856YO1Z64F)  
    CABBAGE (UNII: GW0W1Y9I97)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUNDSize31mm
    FlavorRASPBERRY (raspberry) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-200-014 in 1 KIT
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    Part 3 of 3
    KIDS THROAT  
    aconite 30c, belladonna 30c, chamomilla 30c, phytolacca 30c lozenge
    Product Information
    Item 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:64997-100-014 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(64997-400)

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