Label: ACONITUM- aconitum globule

  • 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 November 24, 2017

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  • ACTIVE INGREDIENT

    Aconitum 30X, HPUS

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

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  • PURPOSE

    For temporary relief of fever, nerve pains, agitation, restlessness. May also be used for standard homeopathic indications or as directed by your physician.

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  • Use:

    For temporary relief of fever, nerve pains, agitation, restlessness. May also be used for standard homeopathic indications or as directed by your physician.

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  • Warnings:

    Consult your health care provider if symptoms persist more than 5 days or worsen.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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  • DO NOT USE

    TAMPER EVIDENT: Do not use if safety seal is broken before first use.

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  • Directions for Use:

    Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

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  • Other Ingredients:

    Sucrose

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  • QUESTIONS

    Developed and Made by

    True Botanica, LLC

    1005 Richards Rd., Suite D

    Hartland, WI 53029

    800-315-8783

    www.truebotanica.com

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ACONITUM 
    aconitum globule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53645-1610
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 30 [hp_X]  in 23 g
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 4mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53645-1610-2 23 g in 1 BOTTLE; Type 0: Not a Combination Product 11/24/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 11/24/2017
    Labeler - True Botanica, LLC (182071519)
    Establishment
    Name Address ID/FEI Business Operations
    True Botanica, LLC 182071519 manufacture(53645-1610)
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