Label: CHILDRENS COUGH- aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica, spongia tosta liquid

  • 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 13, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica, Spongia tosta. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

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  • INDICATIONS & USAGE

    Uses for temporary relief of minor cough symptoms: dry or hoarse cough, tickling cough, cough from mucus drainage or throat irritation. Note: A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, stop use and consult a health care professional.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

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  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
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  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
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  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults: 3 sprays 3 times per day.
    • Children 2-12 years: 2 sprays 3 times per day
    • Use additionally as needed, up to 6 times per day.
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  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

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  • PURPOSE

    Uses ​for temporary relief of minor cough symptoms:

    • dry or hoarse cough
    • tickling cough
    • cough from mucus drainage or throat irritation
    • Note: A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, stop use and consult a health care professional.
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH 
    aconitum napellus, bromium, coccus cacti, corallium rubrum, cuprum metallicum, drosera, hepar sulphuris calcareum, iodium, mephitis mephitica, spongia tosta liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0145
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X]  in 59 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 10 [hp_X]  in 59 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 10 [hp_X]  in 59 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 10 [hp_X]  in 59 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X]  in 59 mL
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X]  in 59 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 10 [hp_X]  in 59 mL
    MEPHITIS MEPHITIS ANAL GLAND FLUID (UNII: 3BN57UN4US) (MEPHITIS MEPHITIS ANAL GLAND FLUID - UNII:3BN57UN4US) MEPHITIS MEPHITIS ANAL GLAND FLUID 10 [hp_X]  in 59 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57955-0145-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/22/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/22/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio Inc. 617901350 manufacture(57955-0145)
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