Label: ALLERGY AND SINUS RELIEF- cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed tablet, orally disintegrating

  • 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 December 12, 2016

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  • SPL UNCLASSIFIED SECTION

    Allergy & Sinus Relief

    Drug Facts

  • Active Ingredients

    Cardiospermum 4X

  • Purpose

    congestion, itchy eyes, runny nose

  • Active Ingredients

    Galphimia glauca 4X

  • Purpose

    runny nose, itchy eyes, sneezing

  • Active Ingredients

    Luffa operculata 6X

  • Purpose

    sneezing, runny nose, congestion

  • Active Ingredients

    Sabadilla 4X

  • Purpose

    sneezing, runny nose, itching

  • Uses*

    According to homeopathic principles, the active ingredients in this medication help temporarily relieve symptoms associated with seasonal allergies, such as:

    • Allergic congestion

    • Itchy eyes, nose or throat

    • Runny nose

    • Watering eyes

    • Sneezing

  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Do not exceed recommended dosage.

    • Not intended for children under 2.

    If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if:

    symptoms worsen or persist for more than 72 hours

  • Directions

    Adults and Children ages 2 and older: Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Lactose, Magnesium stearate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-242-30
    Similasan
    Allergy
    & Sinus
    Relief
    60 Dissolvable Tablets

    PRINCIPAL DISPLAY PANEL NDC 59262-242-30 Similasan Allergy & Sinus Relief 60 Dissolvable Tablets

  • INGREDIENTS AND APPEARANCE
    ALLERGY AND SINUS RELIEF 
    cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP4 [hp_X]
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP4 [hp_X]
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-242-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2017
    Labeler - Similasan Corporation (111566530)
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