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

  • NDC Code(s): 60512-9081-4, 60512-9081-5, 60512-9081-9
  • Packager: HOMEOLAB USA INC
  • 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

If you are a consumer or patient please visit this version.

  • 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

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  • 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

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  • 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.

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  • 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

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  • 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.

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  • 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.

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  • Other information

    • Store at room temperature.

    Do not use if seal is broken or missing.

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  • Inactive ingredients

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

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  • CARTON
  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9081
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP 1 [hp_C]  in 100 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C]  in 100 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_C]  in 100 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 3 [hp_C]  in 100 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 3 [hp_C]  in 100 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 4 [hp_C]  in 100 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 4 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-9081-5 1 in 1 CARTON
    1 100 mL in 1 BOTTLE
    2 NDC:60512-9081-4 30 mL in 1 BOTTLE
    3 NDC:60512-9081-9 1 in 1 CARTON
    3 250 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/28/2011
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-9081)
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