Label: ASTHMACARE- aconitum napellus, adrenalinum, ammonium carbonicum, antimonium tartaricum, aralia racemosa, bromium, chlorinum, eriodictyon californicum, eucalyptus globulus, grindelia, lobelia inflata, natrum sulphuricum, phosphorus, quebracho, trifolium pratense 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 April 1, 2014

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

  • ACTIVE INGREDIENT

    HPUS active ingredients

    _________________________________________________________________________________________________________________

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon Californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense.

  • PURPOSE

    HPUS active ingredients                                           Purpose †

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Aconitum napellus....................................................shortness of breath

    Adrenalinum.............................................................asthma related congestion

    Ammonium carbonicum.............................................breathing difficulties

    Antimonium tararicum...............................................shortmess of breath

    Aralia racemosa........................................................tightness in chest

    Bromium..................................................................spasmodic cough

    Chlorinum................................................................tightness in chest

    Eriodictyon californicum.............................................asthmatic wheezing

    Eucalyptus globulus..................................................mucus congestion

    Grindelia.................................................................bronchial irritation

    Lobelia inflata..........................................................cough, chest discomfort

    Natrum sulphuricum.................................................shortness of breath

    Phosphorus.............................................................asthmatic chest spasms

    Quebracho..............................................................shortness of breath

    Trifolium pratense....................................................tracheal irritation

  • INDICATIONS & USAGE

    Uses

    For temporary relief or minor asthma symptoms such as:

    • shortness of breath
    • tightness in chest
    • wheezing
    • bronchial irritation
    • cough
    • minor breathing difficulties

    † as per various homeopathic Materia Medicas.

  • WARNINGS

    Warnings

    • This product is not a rescue inhaler.
    • Asthma can be life threatening. If you have ever been hospitalized for asthma, consult a physician before using this product. This product is intended to complement, not replace, standard medical treatment.
    • Children with asthma should be under the ongoing supervision of a physician.
    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

    Directions

    Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

    Adult Dose 3 pump sprays 3 times per day.

    Children 6-12 years 2 pump sprays 3 times per day.

    Use additionally as needed, up to 6 times per day.

  • OTHER SAFETY INFORMATION

    Other information:

    Tamper resistant for your protection. Use only if safety seal is intact.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, Potassium sorbate and Purified water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASTHMACARE 
    aconitum napellus, adrenalinum, ammonium carbonicum, antimonium tartaricum, aralia racemosa, bromium, chlorinum, eriodictyon californicum, eucalyptus globulus, grindelia, lobelia inflata, natrum sulphuricum, phosphorus, quebracho, trifolium pratense liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-7044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 29.6 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE10 [hp_X]  in 29.6 mL
    AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CARBONATE10 [hp_X]  in 29.6 mL
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE10 [hp_X]  in 29.6 mL
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT10 [hp_X]  in 29.6 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE10 [hp_X]  in 29.6 mL
    CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820) CHLORINE10 [hp_X]  in 29.6 mL
    ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H) ERIODICTYON CALIFORNICUM LEAF10 [hp_X]  in 29.6 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF10 [hp_X]  in 29.6 mL
    GRINDELIA HIRSUTULA WHOLE (UNII: C08B09D8UJ) (GRINDELIA HIRSUTULA WHOLE - UNII:C08B09D8UJ) GRINDELIA HIRSUTULA WHOLE10 [hp_X]  in 29.6 mL
    LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA10 [hp_X]  in 29.6 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE10 [hp_X]  in 29.6 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 29.6 mL
    ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190) ASPIDOSPERMA QUEBRACHO-BLANCO BARK10 [hp_X]  in 29.6 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER10 [hp_X]  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-7044-11 in 1 CARTON
    159 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-7044)