Label: COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, corallium rubrum, 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 April 8, 2014

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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 - Calculated as 0.0000003% alkaloids

    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 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 traditionally used to help 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 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 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 8 hours or 3 times a day.

    Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 times a day.

  • 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, corallium rubrum, stannum metallicum, chamomilla, coffea cruda syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9081
    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
    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
    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
    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:60512-9081-51 in 1 CARTON
    1100 mL in 1 BOTTLE
    2NDC:60512-9081-430 mL in 1 BOTTLE
    3NDC:60512-9081-91 in 1 CARTON
    3250 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(60512-9081)
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