Label: HEADACHE RELIEF- atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor 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

    Headache Relief

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Belladonna 12X HPUS

    (0.0000000000003% Alkaloids, calculated)

    headache

    Gelsemium Sempervirens 6X HPUS

    headache

    Ipecacuanha 6X HPUS

    headache

    Iris Versicolor 6X HPUS

    headache

    "HPUS" indicates that the active ingredients are in the official Homeopathic

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves headaches

  • Warnings

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

    Do not use more than directed.

    Consult a physician if:

    ■ symptoms persist for more than 7 days or worsen.

    ■ new symptoms occur.

    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 54973-4008-1

    SINCE 1903

    Hyland's

    Headache

    Relief *

    TOUGH ON PAIN - GENTLE ON YOU

    NO ACETAMINOPHEN

    NO IBUPROFEN

    NO KNOWN DRUG

    INTERACTIONS

    100 QUICK-DISSOLVING

    TABLETS

    NATURAL

    RELIEF

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF 
    atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (White to Off white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4008-11 in 1 CARTON04/03/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2020
    Labeler - Hyland's Inc. (008316655)
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!