Label: SEDALIA- aconitum napellus, belladonna leaf, calendula officinalis flowering top, chelidonium majus, abrus precatorius seed, viburnum opulus root 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 May 2, 2018

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  • ACTIVE INGREDIENT

    Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C

  • PURPOSE

    Aconitum napellus 6C Relieves restlessness, agitation

    Belladona 6C Relieves hypersensitivity to stress

    Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise

    Chelidonium majus 6C Relieves digestive symptoms caused by stress

    Jequirity 6C Relieves uneasiness

    Viburnum opulus 6C Relieves nervousness and restless sleep

  • INDICATIONS & USAGE

    For temporary relief of nervousness, hypersensitivity and irritability due to stress.

  • STOP USE

    Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.

  • ASK DOCTOR

    Ask a doctor before use in children younger than 12 years of age.


  • WHEN USING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DESCRIPTION

    Directions: (adults and children 12 years of age and older): Allow 3 tablets to dissolve in the mouth 3 times a day.

  • STORAGE AND HANDLING

    Store at 68-77 o F (20-25 o C)

  • DRUG INTERACTIONS

    Non habit forming, no drug interactions

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate.

  • 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

  • HOW SUPPLIED

    60 tablets

  • WARNINGS


  • DOSAGE & ADMINISTRATION

    Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.

  • PRINCIPAL DISPLAY PANEL

    BOXbox

  • INGREDIENTS AND APPEARANCE
    SEDALIA 
    aconitum napellus, belladonna leaf, calendula officinalis flowering top, chelidonium majus, abrus precatorius seed, viburnum opulus root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9332
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_C]
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF6 [hp_C]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP6 [hp_C]
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS6 [hp_C]
    ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED6 [hp_C]
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK6 [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:0220-9332-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product07/05/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/05/1997
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9332)
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