Label: BERBERIS VULGARIS 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 December 31, 2015

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  • ACTIVE INGREDIENT

    BERBERIS VULGARIS HPUS 1X and Higher

  • USES

    Burning Urine

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.

    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    Lactose

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BERBERIS VULGARIS 
    berberis vulgaris tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0539
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-0539-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15631-0539-14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:15631-0539-250 in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:15631-0539-3100 in 1 CONTAINER; Type 0: Not a Combination Product
    5NDC:15631-0539-4250 in 1 CONTAINER; Type 0: Not a Combination Product
    6NDC:15631-0539-5500 in 1 CONTAINER; Type 0: Not a Combination Product
    7NDC:15631-0539-61000 in 1 CONTAINER; Type 0: Not a Combination Product
    8NDC:15631-0539-710000 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/30/2015
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo, Inc832534981wholesale drug distributor(15631-0539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0539) , label(15631-0539)
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