Label: COUGH AND COLD NIGHTTIME REAL RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea cruda 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 December 14, 2018

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  • ACTIVE INGREDIENTS HPUS

    Drosera (Sundew) 1C

    Arnica montana (Leopard's bane) 3C

    Bryonia (White bryony) 3C

    Cetraria islandica (Iceland moss) 1C

    Belladonna (Deadly nightshade) 3C

    Coccus cacti (Cochineal) 3C

    Corallium rubrum (Red coral) 3C

    Stannum metallicum (Tin) 3C

    Chamomilla (German chamomile) 4C

    Coffea cruda (Coffee) 4C

  • PURPOSE

    dry cough

    aches and pains, chest congestion

    painful cough

    cough with expectoration

    cold and fever

    cough with expectoration

    painful cough

    mucus, cough and chills

    restlessness, irritability and nocturnal awakenings

    restlessness and sleeplessness

  • REFERENCES

    The letters HPUS indicate the ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

  • USES

    This homeopathic medecine helps relieve symptoms associated with nighttime cough and cold:

    - dry cough

    - cough with expectoration

    - chest congestion

    - fever

    - aches and pains

  • WARNINGS


    Do not use if seal is broken or missing.

    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.

    Take before bedtime. Repeat every 8 hours, as needed.

    Reduce intake with improvement or as directed by a healthcare professional.



    Adults and children 12+ yrs: 2 teaspoons.

    Children 6 to 11 years of age: 1 teaspoon.

    Children 2 to 5 years of age: 1/2 teaspoon.

  • OTHER INFORMATION

    Store at room temperature.

  • 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 NIGHTTIME REAL RELIEF 
    drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea cruda syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9084
    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
    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
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_C]  in 250 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [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:60512-9084-91 in 1 CARTON03/21/2012
    1250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9084)
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