Label: HELLEBORUS COMP. A liquid

  • 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 April 1, 2024

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  • 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: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Kalium phos.(potassium dihydrogenphosphate) 6X,Stibium met. (Antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met. (Silver) 8X, Phosphorus (Yellow phosphorus) 12X, Arsenicum (White arsenic) 17X, Plumbum silicicum (Lead silicate) 20X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt, Lactose

  • 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. Contains traces of lactose. 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
    shopuriel.com Lot:

  • PRINCIPAL DISPLAY PANEL

    Helleborus comp. A Ampules

  • INGREDIENTS AND APPEARANCE
    HELLEBORUS COMP. A 
    helleborus comp. a liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-5135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)17 [hp_X]  in 1 mL
    LEAD MONOSILICATE (UNII: TLE92T7F1J) (LEAD - UNII:2P299V784P) LEAD MONOSILICATE20 [hp_X]  in 1 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER8 [hp_X]  in 1 mL
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA6 [hp_X]  in 1 mL
    ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY6 [hp_X]  in 1 mL
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT3 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, MONOBASIC6 [hp_X]  in 1 mL
    JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF7 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-5135-110 in 1 BOX03/11/2021
    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 homeopathic03/11/2021
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-5135)
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