Label: COUGH AND COLD REAL RELIEF- drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, corrallium 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 2, 2014

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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

    Corallium rubrum (Red coral) 3C

    Stannum metallicum (Tin) 3C

  • Purpose

    Dry cough

    Aches and pains, chest congestion

    Painful cough

    Night cough

    Cough with expectoration

    Cold and fever

    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 Homeopathic 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 traditionally used to help 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.

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    • Do not use more than directed.

    • Do not take with food.

    • Repeat every 4 hours and reduce intake with improvement or as directed by a health professional.


    Age:                                         Dose:

    Adults and children 12+ yrs:    2 teaspoons (tsp)

    Children 6 to 11 years of age:  1 teaspoon (tsp)

    Children 2 to 5 years of age:    1/2 teaspoon (tsp)

  • 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

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD REAL RELIEF 
    drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, corrallium rubrum, stannum metallicum syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9085
    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
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON3 [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:60512-9085-91 in 1 CARTON
    1250 mL in 1 BOTTLE
    2NDC:60512-9085-430 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/17/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9085)
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