Label: FEVER REDUCER- aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tablet

  • 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 12, 2022

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

View All Sections
  • PURPOSE

    Temporarily reduces fevers and relieves pain

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Aconitum Napellus 6X HPUS

    fever reducer/pain reliever

    Belladonna 6X HPUS

    (0.0000003% Alkaloids, calculated)

    fever reducer/pain reliever

    Bryonia Alba 6X HPUS

    fever reducer/pain reliever

    Gelsemium Sempervirens 6X HPUS

    fever reducer/pain reliever

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily reduces fevers and relieves pain

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use more than directed.

    Stop use and consult a physician if:

    ■ pain gets worse or lasts more than 7 days.

    ■ fever gets worse, is consistently 103°F (39.4°C) or higher or lasts more than 3 days.

    ■ new symptoms occur.

    ■ redness or swelling is present.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults and children

    12 years and over

    Dissolve 2 tablets under tongue every 15 minutes

    up to 4 doses, then every 4 hours until relieved.

    Children under 12 years

    Consult a physician.

  • Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

    NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Principal Display Panel

    HOMEOPATHIC

    NDC 54973-4010-1

    SINCE 1903

    Hyland's

    Fever

    Reducer*

    TOUGH ON PAIN - GENTLE ON YOU

    NO ACETAMINOPHEN

    NO IBURPTOFEN

    NO KNOWN DRUG

    INTERACTIONS

    HFVR

  • INGREDIENTS AND APPEARANCE
    FEVER REDUCER 
    aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4010-11 in 1 CARTON03/30/2020
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/30/2020
    Labeler - Hyland’s Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4010) , pack(54973-4010) , label(54973-4010)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!