Label: MIGRAINE HEADACHE THERAPY- atropa belladonna - bryonia alba root - black cohosh - arabica coffee bean - nitroglycerin - iris versicolor root - sodium chloride - tablet, orally disintegrating

  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Belladonna HPUS6x, 12xPounding, Throbbing Headache
    Bryonia HPUS6x, 12x, 18xPressure Headache, Vertigo
    Cimicifuga racemosa HPUS6x, 12x, 18xLightheadedness
    Coffea crudaHPUS 3xIntolerable Pain, Sensitivity
    Glonoinum HPUS12x, 18xBursting Headache, Vertigo
    Iris versicolor HPUS6x, 12x, 18xSick Headache, Nausea
    Natrum muriaticum HPUS6x, 12x, 18xBlinding Headache, Blurred Vision

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

  • PURPOSE

  • INDICATIONS & USAGE

    Uses:*

    According to homeopathic indications, these ingredients provide temporary relief for symptoms such as: • Pressure • Throbbing • Light and noise sensitivity after diagnosis by a physician.

    *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS

    Warnings:

    USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

    • This product is intended to complement, not replace, standard medical treatment.
    • Initial worsening of symptoms may occur.
    • A physician should always be consulted to rule out serious causes.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

  • WARNINGS

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

    Stop use and ask a doctor if:

    • You experience worsening symptoms.
    • If symptoms last longer than 7 days.
  • Directions

    • Suitable for adults and children 12 years and above.
    • Dissolve entire tablet under tongue.
    • Do not chew or swallow whole.
    • Take 1 tablet 3 times a day or as directed by a physician.
    • Use up to 6 times a day as needed.
    • Take at least 10 minutes before or at least 10 minutes after eating or drinking.
    • Children under the age of 12: consult a physician before use.
    • May take up to 60 days to see results.
    • Homeopathic remedies may not be effective for everyone.
  • Other information

    • There are no known contraindications.
    • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
    • Store in a cool dark location.
    • Migraine Headache Therapy™ Homeopathic Fast Dissolving Tablet are homeopathic dilutions: see www.thereliefproducts.com for details.
  • Inactive Ingredients

    Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

  • Do not use if tamper evident seal is torn, broken or missing.

  • QUESTIONS

    Questions or comments? www.thereliefproducts.com, 1-888-969-6855

  • PRINCIPAL DISPLAY PANEL

    Box
    Label


  • INGREDIENTS AND APPEARANCE
    MIGRAINE HEADACHE THERAPY 
    atropa belladonna - bryonia alba root - black cohosh - arabica coffee bean - nitroglycerin - iris versicolor root - sodium chloride - tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITOL (UNII: 506T60A25R)  
    CROSPOVIDONE (UNII: 68401960MK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    COPOVIDONE (UNII: D9C330MD8B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeDIAMONDSize13mm
    FlavorImprint Code TRP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-041-141 in 1 PACKAGE04/01/2016
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2016
    Labeler - TRP Company (105185719)
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