Label: NUX VOMICA 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 November 1, 2023

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

  • INDICATIONS & USAGE SECTION

    Formulated for indigestion and stress.

  • DOSAGE & ADMINISTRATION SECTION

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

  • OTC - ACTIVE INGREDIENT SECTION

    1% Nux vomica 12x

  • OTC - PURPOSE SECTION

    Formulated for indigestion and stress.

  • 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
    NUX VOMICA 
    nux vomica pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57556-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57556-016-0214 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2022
    Labeler - Historical Remedies (627758634)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(57556-016)