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

  • NDC Code(s): 68466-4098-1
  • Packager: Schwabe Mexico S.A. de C.V
  • Category: HUMAN OTC DRUG LABEL

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 November 11, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Aconitum napellus 3X

    Hepar sulphuris calcareum (Calcium Sulfide) 12X

    Spongia tosta 3X

    Stannum metallicum (Tin) 12X

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Lactose monohydrate

    Magnesium stearate

    Microcrystalline cellulose

  • PURPOSE

    PURPOSE:

    Uses: Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion

  • DOSAGE & ADMINISTRATION

    Directions: Sublingual medication.

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

    Adults and children 12 years of age and older: 2 tablets every two hours until relieved.

    Children under 12 years of age: Consult a doctor.

  • INDICATIONS & USAGE

    NDICATIONS AND USAGE:

    Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion.

  • WARNINGS

    WARNINGS:

    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.

  • PREGNANCY OR BREAST FEEDING

    Pregnancy or Breast Feeding:

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

  • KEEP OUT OF REACH OF CHILDREN

    Children:

    Keep out of the reach of children.

  • ASK DOCTOR

    Ask a doctor before use if you have :

    a persisient or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emplysema or is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptons 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 a rash or persistent headache.

    These could be signs of a serious condition.

  • OVERDOSAGE

    Overdosage:

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

  • PRINCIPAL DISPLAY PANEL

    Bronchial_Breathing_Aide_21814098_04.jpgBronchial_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:68466-4098
    Route of AdministrationSUBLINGUAL, SUBLINGUAL
    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:68466-4098-11 in 1 BOX04/01/2017
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2017
    Labeler - Schwabe Mexico S.A. de C.V (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico S.A. de C.V.812805901manufacture(68466-4098)