Label: ACONITUM NAPELLUS- aconite pellet

  • 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 October 27, 2023

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  • INDICATIONS & USAGE SECTION

    Formulated for susceptibility to colds.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Adults4 pellets; Children(4-12 years) 2 pellets; Dissolve under the tongue. Take every half hour as needed, or 4 times a day.

  • OTC - ACTIVE INGREDIENT SECTION

    1% Aconitum napellus 12x

  • OTC - PURPOSE SECTION

    Formulated for susceptibility to colds.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Organic beet-derived sucrose; gluten-free, lactose-free, non-GMO

  • QUESTIONS SECTION

    Distributed by Historical Remedies; 122 S Wabasha, Saint Paul, MN 55107; 800-676-6654

    www.historicalremedies.com

  • WARNINGS SECTION

    Warning: Consult a doctor if symptoms persist more than 3 days or worsen. If pregnant or nursing, ask a doctor before use. Keep out of reach of children. Do not use if tamper-evident band is missing or broken.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding,ask a doctor before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    ACONITUM NAPELLUS 
    aconite pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57556-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57556-010-0214 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2021
    Labeler - Historical Remedies (627758634)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(57556-010)
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