Label: ALLERGIEMITTEL- cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet

  • NDC Code(s): 68466-2590-4
  • Packager: Schwabe Mexico S.A. de C.V.
  • 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 30, 2020

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

  • ACTIVE INGREDIENT

    Cardiospermum halicabum 3X

    Galphimia glauca 3X

    Luffa operculate 4X

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Lactose monohydrate

    Magnesium stearate

    Microcrystalline cellulose

  • PURPOSE

    OTC Purpose

    Temporarily relieves minor allergic symptoms: sneezing, runny, stuffy, itchy nose, red, itchy, watery eyes, scratchy throat.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indications and Usage:

    For temporary relief of minor allergic symptoms such as sneezing; runny, stuffy, itchy nose; red, watery, or itching eyes; scratchy throat.

  • WARNINGS

    Stop use and ask a doctor if symptoms worsen, do not improve, are accompanied by a fever, or if new symptoms occur..

    In the event of severe allergic reactions, consult a doctor immediately.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Sublingual medication: Place under tongue and let dissolve.

    Take before exposure to allergen or as soon after symptoms appear as possible, at least 15 minutes before or half an hour after eating, brushing teeth, or drinking anything except water.

    Adults and Children 12 Years and older: Take 1 tablet every hour until symptoms subside, then 1 tablet 3 times per day until relieved.
    Children 6 to 12: Take 1/2 tablet every hour until symptoms subside, then 1/2 tablet 2 times a day until relieved.
    Children under 2: Consult a doctor.

    Preventative use: Take 4-6 weeks before allergy season starts: 1 tablet 3 times a day

  • PREGNANCY OR BREAST FEEDING

    Pregnancy or Breast Feeding:

    If pregnany or breastfeeding, ask a healthcare professional before use.

  • OVERDOSAGE

    Overdosage:

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

  • ASK DOCTOR

    Ask the Doctor:

    Stop use and ask a doctor if symptoms worsen, do not improve, are accompanied by a fever, or if new symptoms occur.
    In the event of severe allergic reactions, consult a doctor immediately.

  • PRINCIPAL DISPLAY PANEL

    21812590_Allergiemittel_05.jpg21812590_Allergiemittel_05.jpg21812590_Allergiemittel_05.jpg

  • INGREDIENTS AND APPEARANCE
    ALLERGIEMITTEL 
    cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-2590
    Route of AdministrationSUBLINGUAL, SUBLINGUAL, SUBLINGUAL, SUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP3 [hp_X]
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP3 [hp_X]
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (BT) Scoreno score
    ShapeROUND (BT) Size10mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68466-2590-44 in 1 CARTON04/01/201701/30/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/201701/30/2025
    Labeler - Schwabe Mexico S.A. de C.V. (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico S.A. de C.V.812805901manufacture(68466-2590)