Label: ARNICA PLUS MUSCLE AND JOINT PAIN REAL RELIEF- arnica, hypericum perforatum tablet, chewable

  • 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 November 21, 2012

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  • ACTIVE INGREDIENTS HPUS

    Arnica (Leopard's bane) 6X

    Hypericum perforatum (St-John's wort) 6X

  • PURPOSE

    joint pain, bruises, sprains, soreness, muscle aches, stiffness

    bruises, strains

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    USES

    This homeopathic medicine helps relieve symptoms associated with:

    - joint pain

    - strains

    - sprains

    - soreness

    - stiffness

    - bruises

    - muscle aches

  • WARNINGS


    Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

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

    Keep out of reach of children.

  • DIRECTIONS

    Chew tablets and let dissolve in mouth.

    Do not use more than directed.

    Do not take with food.

    Repeat every 4 hours, and reduce intake with improvement or as directed by a health professional.

    AgeDose
    Adults and children 12 years of age and older2 tablets
    Children 2 to 11 years of age1 tablet

  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    ARNICA PLUS MUSCLE AND JOINT PAIN  REAL RELIEF
    arnica, hypericum perforatum tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [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:60512-6025-090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/21/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6025)
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