ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELET

ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELET
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NDC 0220-9321-04
Set ID 041b3a33-a2b6-4ab5-beec-f343de96f542
Category HUMAN OTC DRUG LABEL
Packager Laboratoires Boiron
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Arnica montana 3C, Arum triphyllum 3C, Belladonna 3C, Bromium 3C, Bryonia alba 3C, Mercuris solubilis 4C, Phytolacca decandra 3C, Pulsatilla 3C, Spongia tosta 3C

  • PURPOSE

    Arnica montana 3C Relieves hoarseness due to overexertion of the vocal cords
    Arum triphyllum 3C Relieves vocal cord fatigue in speakers and singers
    Belladonna 3C Relieves red and sore throat
    Bromium 3C Relieves swollen and painful tonsils
    Bryonia alba 3C Relieves sore throat with intense thirst
    Mercuris solubilis 4C Relieves sore throat with intense salivation
    Phytolacca decandra 3C Relieves sore throat with pain spreading to the ears
    Pulsatilla 3C Relieves raw sore throat
    Spongia tosta 3C Relieves hoarseness with dry throat

  • INDICATIONS & USAGE

    Temporary relieves minor sore throat and hoarseness.

  • STOP USE

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

  • ASK DOCTOR

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

    If sore throat is severe, accompanied or followed by fever, headache, rash nausea or vomiting.

  • 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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour. Then, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.
    Children under 12 years of age: Ask a doctor.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate.

  • QUESTIONS

    Questions, Comments
    www.boironusa.com
    info@boironusa.com

    1-800-BOIRON-1
    (1-800-264-7661)
    Distributed by Boiron Inc.
    6 campus boulevard
    Newtown Square, PA
    19073-3267

  • HOW SUPPLIED

    60 tablets

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    Roxalia image Roxalia image

  • INGREDIENTS AND APPEARANCE
    ROXALIA 
    arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT3 [hp_C]
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF3 [hp_C]
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE3 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS4 [hp_C]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_C]
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [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:0220-9321-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product10/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2013
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9321)

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