Label: AURUM ONOPORDON liquid

  • Category: HUMAN OTC DRUG LABEL

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 17, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • DOSAGE & ADMINISTRATION

    Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

  • ACTIVE INGREDIENT

    Active Ingredients: 100gm contains: 12.5gm Onopordon (Cotton thistle) 2X, 12.5gm Primula (Cowslip) 2X, 5gm Hyoscyamus (Henbane) 4X; Arnica 10X, Aurum met. (Metallic gold) 10X, Formica (Red wood ant) 10X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

  • QUESTIONS

    Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    AurumOnopordonAmpules

  • INGREDIENTS AND APPEARANCE
    AURUM ONOPORDON 
    aurum onopordon liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1199
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONOPORDUM ACANTHIUM FLOWER (UNII: AP97AUF88E) (ONOPORDUM ACANTHIUM FLOWER - UNII:AP97AUF88E) ONOPORDUM ACANTHIUM FLOWER2 [hp_X]  in 1 mL
    PRIMULA VERIS FLOWER (UNII: W5BET37294) (PRIMULA VERIS FLOWER - UNII:W5BET37294) PRIMULA VERIS FLOWER2 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER LEAF (UNII: 32IT7G8BAW) (HYOSCYAMUS NIGER LEAF - UNII:32IT7G8BAW) HYOSCYAMUS NIGER LEAF4 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD10 [hp_X]  in 1 mL
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1199-110 in 1 BOX09/01/2009
    11 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-1199)