Label: MIGRAINE RELIEF- gelsemium sempervirens root, strychnos nux-vomica seed, iris versicolor root, sanguinaria canadensis root, atropa belladonna and nitroglycerin 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 13, 2022

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  • PURPOSE

    Migraine Relief

  • Drug Facts

    Active ingredients

    Active ingredients

    Purpose

    Belladonna 6X HPUS

    (0.0000003% Alkaloids, calculated)

    pounding pain, light and noise sensitivity

    Gelsemium 6X HPUS

    dull headache

    Glonoinum 12X HPUS

    throbbing headache, dizziness

    Iris Versicolor 6X HPUS

    headache, blurred vision, nausea

    Nux Vomica 6X HPUS

    (0.0000016% Alkaloids, calculated)

    frontal headache, dizziness

    Sanguinaria Canadensis 6X HPUS

    headache

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

    Pharmacopoeia of the United States.

  • Uses

    ■ Temporarily relieves symptoms of adult migraine headaches including:

    ■ throbbing headache ■ pounding pain ■ dull headache

    ■ frontal headache ■ light sensitivity ■ noise sensitivity

    ■ dizziness ■ nausea ■ blurred vision

  • Warnings

    Ask a doctor before use if you have

    ■ never had migraines diagnosed by a health professional. ■ a headache that is different from your usual migraines. ■ the worst headache of your life. ■ fever and stiff neck. ■ headaches beginning after or caused by head injury, exertion, coughing or bending. ■ experienced your first headache after the age of 50. ■ daily headaches.  a migraine so severe as to require bed rest. ■ been vomiting with your migraine headache.

    Stop use and ask a doctor if

    ■ an allergic reaction occurs. ■ you feel faint. ■ your migraine is not relieved or worsens after first dose. ■ new or unexpected symptoms occur. ■ ringing in the ears or loss of hearing occurs.

    If pregnant or breastfeeding

    Ask a health professional before use.

    Keep out of reach of children.

  • Directions

    ■ Use as directed.

    Adults and children
    12 years and over     		At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved.
    Children under
    12 years of age     		Ask a doctor before use.

  • Drug Facts (continued)

    Inactive ingredients

    Acacia Gum, Lactose.

    Questions?

    www.hylands.com or care@hylands.com

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL

    Hyland's

    NATURALS

    MIGRAINE

    RELIEF*

    TOUGH ON PAIN - GENTLE ON YOU

    NO Acetaminophen

    NO Ibruprofen

    NO Known

    Drug Interactions

    NO Caffeine

    100

    QUICK - DISSOLVING

    TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    MIGRAINE RELIEF 
    gelsemium sempervirens root, strychnos nux-vomica seed, iris versicolor root, sanguinaria canadensis root, atropa belladonna and nitroglycerin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [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:54973-4030-11 in 1 CARTON03/30/2020
    1100 in 1 BOTTLE; 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(54973-4030) , pack(54973-4030) , label(54973-4030)
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