Label: KIDS RELIEF COUGH AND COLD- drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, 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 April 12, 2017

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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

    Coccus cacti (Cochineal) 3C

    Corallium rubrum (Red coral) 3C

    Stannum metallicum (Tin) 3C

  • Purpose

    Dry cough

    Aches and pains, chest congestion

    Painful cough, fever

    Night cough

    Cough with expectoration

    Cough with expectoration

    Painful cough

    Cough, chills and lessens mucus

  • REFERENCES

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

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • Uses

    This homeopathic medicine is made from a combination of ingredients tracitionally used tohelp 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 if

    - pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

    - fever gets worse or lasts more than 3 days

    - redness or swelling is present

    - new symptoms occur

    - cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

  • Directions

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

    Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

  • Other information

    Store at room temperature.

    Do not use if seal under bottle cap is broken or missing.

  • Inactive ingredients

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

  • CARTON

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF COUGH AND COLD 
    drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP1 [hp_C]  in 100 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]  in 100 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]  in 100 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 100 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 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:60512-9210-51 in 1 CARTON11/01/2016
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:60512-9210-41 in 1 CARTON11/04/2016
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:60512-9210-91 in 1 CARTON11/04/2016
    3250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2016
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9210)
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