Label: ACONITUM BELLADONNA- aconitum napellus, atropa belladonna and toxicodendron pubescens leaf pellet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

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  • DOSAGE & ADMINISTRATION

    Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

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  • ACTIVE INGREDIENT

    Active Ingredients: Aconitum e tub. 30X, Atropa belladonna e rad. 30X, Rhus tox. e fol. 30X

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  • INACTIVE INGREDIENT

    Inactive Ingredient: Sucrose

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  • PURPOSE

    Use: Temporary relief of headache.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • WARNINGS

    Warnings: Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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.

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  • QUESTIONS

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

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  • INGREDIENTS AND APPEARANCE
    ACONITUM BELLADONNA 
    aconitum belladonna pellet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:48951-9167
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 30 [hp_X]
    ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 30 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 3mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48951-9167-2 1350 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    Name Address ID/FEI Business Operations
    Uriel Pharmacy Inc. 043471163 manufacture(48951-9167)
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