Label: ACONITUM globule

  • 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 November 24, 2017

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

  • ACTIVE INGREDIENT

    Aconitum 30X, HPUS

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

  • PURPOSE

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

  • Use:

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

  • Warnings:

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DO NOT USE

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

  • 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.

  • Other Ingredients:

    Sucrose

  • QUESTIONS

    Developed and Made by

    True Botanica, LLC

    1005 Richards Rd., Suite D

    Hartland, WI 53029

    800-315-8783

    www.truebotanica.com

  • Principal Display Panel

    Aconitum 30X

  • INGREDIENTS AND APPEARANCE
    ACONITUM 
    aconitum globule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53645-1610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT30 [hp_X]  in 23 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53645-1610-223 g in 1 BOTTLE; Type 0: Not a Combination Product11/24/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/24/2017
    Labeler - True Botanica, LLC (182071519)
    Establishment
    NameAddressID/FEIBusiness Operations
    True Botanica, LLC182071519manufacture(53645-1610)