Label: KIDS COUGH- drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipecacuhuana 30c, pulsatilla 30c, belladonna 30c kit

  • 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 29, 2014

If you are a consumer or patient please visit this version.

  • 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:76509-800
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76509-800-011 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:76509-152
    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:76509-152-014 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:76509-150
    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:76509-150-014 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:76509-180
    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:76509-180-014 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 - Natures Investment Holdings Pty Ltd dba Maxrelief USA (745559703)