Label: SECALE BETULA 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 July 30, 2021

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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: Betula e fol. (Silver birch leaves) 3X, Betula e cort. (Silver birch bark) 4X, Levisticum (Lovage) 6X, Nicotiana (Tobacco) 6X, Secale corn. e grano (Ergot) 6X, Galena (Lead glance) 8X, Retina et chor. (Bovine retina and choroid) 8X, Arnica 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
    www.urielpharmacy.com Lot:

  • PRINCIPAL DISPLAY PANEL

    Secale Betula Ampules

  • INGREDIENTS AND APPEARANCE
    SECALE BETULA 
    secale betula liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-8379
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    BETULA PENDULA LEAF (UNII: 5HW39H9KDH) (BETULA PENDULA LEAF - UNII:5HW39H9KDH) BETULA PENDULA LEAF3 [hp_X]  in 1 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM6 [hp_X]  in 1 mL
    LEAD SULFIDE (UNII: 2425D15SYM) (LEAD - UNII:2P299V784P) LEAD SULFIDE8 [hp_X]  in 1 mL
    BOS TAURUS EYE (UNII: VTW461N43P) (BOS TAURUS EYE - UNII:VTW461N43P) BOS TAURUS EYE8 [hp_X]  in 1 mL
    BETULA PENDULA BARK (UNII: 40S83Y133C) (BETULA PENDULA BARK - UNII:40S83Y133C) BETULA PENDULA BARK4 [hp_X]  in 1 mL
    LEVISTICUM OFFICINALE ROOT (UNII: 46QZ19OEX8) (LEVISTICUM OFFICINALE ROOT - UNII:46QZ19OEX8) LEVISTICUM OFFICINALE ROOT6 [hp_X]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-8379-110 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(48951-8379)
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