Label: ABB- aconitum napellus, bryonia alba, belladonna liquid

  • NDC Code(s): 60986-2030-5
  • Packager: MARCO PHARMA INTERNATIONAL LLC
  • 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 December 9, 2021

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  • ACTIVE INGREDIENTS

    ACONITUM NAPELLUS 3X HPUS

    BRYONIA ALBA 3X HPUS

    BELLADONA 3X HPUS

  • INACTIVE INGREDIENT

    ETHYL ALCOHOL (20% BY VOL) AND WATER

  • PURPOSE

    FOR TEMPORARY RELIEF OF COLD AND FLU SYMPTOMS WITH TEMPERATURE

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN

  • WARNINGS

    IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE

  • WARNINGS

    IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.

  • INDICATIONS & USAGE

    FOR TEMPORARY RELIEF OF COLD AND FLU SYMPTOMS WITH TEMPERATURE

  • DOSAGE & ADMINISTRATION

    ADULTS AND CHILDREN: DAY 1; TAKE 5 DROPS ON THE TONGUE EVERY 15 MINUTES FOR 2 HOURS. THEN TAKE 5 DROPS ONCE EVERY HOUR. DAY 2; TAKE 5 DROPS ONCE EVERY HOUR. DAY 3; TAKE 5 DROPS EVERY TWO HOURS. CONTINUE WITH 10 DROPS THREE TIMES DAILY

  • PRINCIPAL DISPLAY PANEL

    ABB_M10022

  • INGREDIENTS AND APPEARANCE
    ABB 
    aconitum napellus, bryonia alba, belladonna liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-2030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 100 mL
    BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE3 [hp_X]  in 100 mL
    BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF3 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-2030-520 mL in 1 BOTTLE; Type 0: Not a Combination Product01/27/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/22/2015
    Labeler - MARCO PHARMA INTERNATIONAL LLC (161994277)
    Registrant - MARCO PHARMA INTERNATIONAL LLC (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDINATURA INC102783016manufacture(60986-2030)
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