Label: CRATAEGUS 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 April 25, 2018

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

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT


    Active Ingredients: 100g contains: 50g Onopordon (Cotton thistle) 2X, 50g Primula (Cowslip) 2X, 20g Hyoscyamus (Henbane) 3X; Crataegus (Hawthorn) 3X, Cactus (Queen of the night) 4X, Cor (Bovine heart) 6X, Aurum met. (Metallic gold) 15X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Propolis

  • 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. Do not use if safety seal is broken or missing.

    REFRIGERATE AFTER OPENING.
    BEST WHEN USED WITHIN 30 DAYS OF OPENING.

  • QUESTIONS

    Questions? Call 866.642.2858
    Made with care by Uriel, East Troy, WI 53120
    www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    CrataegusOnopordonLiquid

  • INGREDIENTS AND APPEARANCE
    CRATAEGUS ONOPORDON 
    crataegus onopordon liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-3136
    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 LEAF3 [hp_X]  in 1 mL
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER3 [hp_X]  in 1 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]  in 1 mL
    BEEF HEART (UNII: P47W069U38) (BEEF HEART - UNII:P47W069U38) BEEF HEART6 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-3136-360 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2009
    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(48951-3136)