Label: HELLEBORUS COMP. F 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 September 26, 2023

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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: Bulbus olfactorius (Bovine olfactory bulb) 8X, Arnica 12X, Helleborus (Christmas rose) 12X, Jaspis (Jasper) 12X, Tunica mucosa nasi (Bovine nasal mucosa) 12X

  • 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
    shopuriel.com Lot:

  • PRINCIPAL DISPLAY PANEL

    Helleborus comp. F

  • INGREDIENTS AND APPEARANCE
    HELLEBORUS COMP. F 
    helleborus comp. f liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-5130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    BOS TAURUS OLFACTORY BULB (UNII: S46V5TR3J8) (BOS TAURUS OLFACTORY BULB - UNII:S46V5TR3J8) BOS TAURUS OLFACTORY BULB8 [hp_X]  in 1 mL
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT12 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    BOS TAURUS NASAL MUCOSA (UNII: 343455G79K) (BOS TAURUS NASAL MUCOSA - UNII:343455G79K) BOS TAURUS NASAL MUCOSA12 [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:48951-5130-110 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, Inc043471163manufacture(48951-5130)
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