Label: COUGH AND COLD KIDS RELIEF- drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, stannum metallicum syrup

  • 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 August 8, 2012

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  • ACTIVE INGREDIENTS HPUS

    Drosera (Sundew) 1C

    Arnica montana (Leopard`s bane) 3C

    Bryonia (White bryony) 3C

    Ipecacuanha (Ipecac) 3C

    Cetraria islandica (Iceland moss) 1C

    Belladonna (Deadly nightshade) 3C

    Coccus cacti (Cochineal) 3C

    Stannum metallicum (Tin) 3C

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Dry cough.

    Aches and pains, chest congestion.

    Painful cough.

    Night cough.

    Cough with expectoration.

    Cold and fever.

    Cough with expectoration.

    Cough, chills and lessens mucus.

  • USES

    This homeopathic medicine helps relieve symptoms associated with cough and cold:

    - dry cough

    - cough with expectoration

    - chest congestion

    - fever

    - aches and pains

  • WARNINGS


    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 5 days.

    Keep out of reach of children.

  • DIRECTIONS

    Do not use more than directed.

    Do not take with food.

    Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional.

    AGEDose
    Children 6 years of age and older1 teaspoon
    Children 2 to 5 years of age 1/2 teaspoon
    Children under 2 years of age Ask a Doctor

  • OTHER INFORMATION

    Store at room temperature.

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD KIDS RELIEF 
    drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, stannum metallicum syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA1 [hp_C]  in 250 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]  in 250 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]  in 250 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_C]  in 250 mL
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 250 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_C]  in 250 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 250 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9011-5100 mL in 1 BOTTLE
    2NDC:60512-9011-430 mL in 1 BOTTLE
    3NDC:60512-9011-9250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/08/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9011)
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