Label: COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea cruda syrup

  • Category: HUMAN OTC DRUG LABEL

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 INGREDIENT

    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

    Stannum metallicum (Tin) 3C

    Chamomilla (German chamomile) 4C

    Coffea cruda (Coffee) 4C

  • REFERENCES

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

  • PURPOSE

    Dry cough.

    Aches and pains, chest congestion.

    Painful cough.

    Cough with expectoration.

    Cold and fever.

    Cough with expectoration.

    Mucus, cough and chills.

    Restlessness, irritability and nocturnal awakenings.

    Restlessness and sleeplessness.

  • USES

    This homeopathic medicine helps relieve symptoms associated with nighttime 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.

    Take before bedtime. Repeat every 8 hours, as needed. Reduce intake with improvement or as directed by a healthcare professional.

    AgeDose
    Children 6 years of age and older 1 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 NIGHTTIME FORMULA KIDS 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:60512-9021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA1 [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
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 100 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_C]  in 100 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [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:60512-9021-9250 mL in 1 BOTTLE
    2NDC:60512-9021-5100 mL in 1 BOTTLE
    3NDC:60512-9021-430 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/28/2011
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9021)
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