Label: ARNICARE ARNICA- arnica montana tablet

  • NDC Code(s): 0220-9059-04, 0220-9059-29
  • Packager: Laboratoires Boiron
  • 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 July 18, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each tablet)

    Arnica Montana 9C HPUS (2.5 mg)

    The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Arnica montana 9C HPUS (2.5 mg) ... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises.

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls
    • reduces symptoms of brusing such as:
    • pain
    • swelling
    • discoloration
  • WARNINGS


  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 6 years of age or older - At the onset of symptoms, dissolve 2 tablets under the tongue and repeat every hour for 2 more hours. Then, dissolve 2 tablets under the tongue every 6 hours until symptoms are relieved.

    Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon for easier intake. Follow directions above.

    Children under 2 years of age - Ask a doctor.

  • INACTIVE INGREDIENT

    croscarmellose sodium, lactose, magnesium, stearate

  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if the blister seal is broken
    • store below 86°F (30°C)

    No known drug interactions

    Non-drowsy

    No Acetaminophen

    No Ibuprofen

    Meltaway Tablets Require No Food or Water

    Paid Relief*

    Swelling & Bruise from Injuries Muscle Pain*

    Gentle on the Stomach

    NSAID-Free

    60 Meltaway Tablets unflavored

    120 Meltaway Tablets unflavored

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • QUESTIONS

    Questions or Comments?

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1
    (1-800-264-7661)

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

    Made in France

  • PRINCIPAL DISPLAY PANEL

    labellabelbox

  • INGREDIENTS AND APPEARANCE
    ARNICARE ARNICA 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9059
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA9 [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:0220-9059-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product07/11/2011
    2NDC:0220-9059-29120 in 1 BLISTER PACK; Type 0: Not a Combination Product04/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/11/2011
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9059)