Label: ACONITUM NAPELLUS- aconite granule

  • 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 September 20, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    ACONITUM NAPELLUS 12CH GR

    ACONITUM NAPELLUS 15CH GR

    ACONITUM NAPELLUS 200K GR

    ACONITUM NAPELLUS 30CH GR

    ACONITUM NAPELLUS 30K GR

    ACONITUM NAPELLUS 5CH GR

    ACONITUM NAPELLUS 6CH GR

    ACONITUM NAPELLUS 7CH GR

    ACONITUM NAPELLUS 9CH GR

    ACONITUM NAPELLUS CMK GR

    ACONITUM NAPELLUS MK GR

    ACONITUM NAPELLUS XMK GR

  • PURPOSE

    Uses

    For the temporary relief of occasional restlessness and tension

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.

    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact
    a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose (milk), sucrose

  • DOSAGE & ADMINISTRATION

    Directions

    Adults: Take 5 granules 3 times daily or as recommended by your healthcare practitioner.

    Children: Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of occasional restlessness and tension

    Directions

    Adults: Take 5 granules 3 times daily or as recommended by your healthcare practitioner.

    Children: Take under the direction of your healthcare practitioner.

  • OTHER SAFETY INFORMATION

    Other Information

    Keep dry.

  • PRINCIPAL DISPLAY PANEL

    62106-7197

    UNDA

    Do not use if label perforation is broken.

    Homeopathic Remedy

    NDC : 62106-7197-4

    ACONITUM NAPELLUS

    Aconite

    140 granules

    For the temporary relief of roccasional restlessness and tension

  • INGREDIENTS AND APPEARANCE
    ACONITUM NAPELLUS 
    aconite granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-7197
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-7197-410 in 1 CARTON01/21/201507/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/21/201507/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-7197)
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