Label: BRONCHIAL AND BREATHING AIDE- aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet

  • NDC Code(s): 53499-9498-2
  • Packager: Schwabe North America, 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 July 26, 2022

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  • Active Ingredients

    Aconitum napellus 3X

    Hepar sulphuris calcareum 12X 

    Spongia tosta 3X

    Stannum metallicum 12X

  • Inactive Ingredients

    Cellulose

    Lactose monohydrate

    Magnesium stearate

  • Purpose

    Loosen phlegm (mucus),

    thins bronchial secretions,

    relieves bronchial congestion

  • Indications & Usage

    Loosen phlegm (mucus),

    thins bronchial secretions,

    relieves bronchial congestion

  • Dosage & Administration

    Sublingual mediation.

    Place tablet under tonge at least 15 minutes before or 30 minutes after eating, brushing teeth or drinking anything except water.

    Adults & Children 12 years of age and over: Take 2 tablets every 2 hours until relieved

    Children under 12 years of age: Consult a doctor

  • Warning

    Sore Throat Warning:  severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.

    Consult a physician promptly.

  • Ask Doctor

    Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days for adults or 5 days for children, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious condition. 

  • Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of the reach of children.

  • Overdosage

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    Bronchial_Breathing_Aide_21814098_04.jpg

  • INGREDIENTS AND APPEARANCE
    BRONCHIAL AND BREATHING AIDE 
    aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9498
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]
    Tin (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) Tin12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (B;T) Scoreno score
    ShapeROUND (BT) Size8mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9498-21 in 1 BOX04/01/201703/31/2027
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/201703/31/2027
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico SA DE CV812805901manufacture(53499-9498)
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