Label: SINUSALIA- belladonna leaf, sanguinaria canadensis root, spigelia tablet

  • 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 February 27, 2020

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  • ACTIVE INGREDIENT

    Belladonna 3C, Sanguinaria canadensis 3C, Spigelia anthelmia 3C

  • INDICATIONS & USAGE

    Temporary relieves nasal congestion and pain due to the common cold or allergies.

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate.

  • HOW SUPPLIED

    60 tablets

  • PURPOSE

    Belladonna 3C HPUS relieves sinus pain with stuffy nose
    (contains less than 10 -8 mg alkaloids)

    Sanguinaria canadensis 3C HPUS relieves sinus pain with runny nose

    Spegelia anthelmia 3C HPUS relieves sinus pain with postnasal drip


  • STORAGE AND HANDLING

    Store at 68-77 o  F (20-25 o C)

  • QUESTIONS

    Questions, Comments
    www.boironusa.com
    info@boironusa.com
    1-800-BOIRON-1 (1-800-264-7661)
    Boiron Information Center
    6 campus Bouelvard
    Newtown Square, PA
    19073-3267

  • ASK DOCTOR

    Ask a doctor before use in children younger than 6 years of age.

    If symptoms are accompanied by fever.


  • STOP USE

    Stop use and ask a doctor if symptoms persist continuously for more than 3 days or worsen.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

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

  • WHEN USING


  • DRUG INTERACTIONS

    Non drowsy, no drug interactions

  • WARNINGS

    Do not use if blister seal is broken

  • DOSAGE & ADMINISTRATION

    (adults and children 6 years of age and older)
    Take 1 dose (2 tablets) every 2 hours up to 6 times a day.
    Allow tablets to dissolve in the mouth.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    SINUSALIA 
    belladonna leaf, sanguinaria canadensis root, spigelia tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF3 [hp_C]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_C]
    SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B) SPIGELIA MARILANDICA ROOT3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (BOIRON) Size9mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9341-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product04/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2011
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9341)
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