Label: HEADACHE/MIGRAINE RELIEF- cyclamen europaeum, antimonium crudum, alumina, lycopodium clavatum, argentum nitricum, digitalis purpurea, melilotus officinalis, glonoinum pellet

  • 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 22, 2020

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  • ACTIVE INGREDIENTS HPUS

    Cyclamen europaeum 4X

    Antimonium crudum 9X

    Alumina 9X

    Lycopodium clavatum 5X

    Argentum nitricum 9X

    Digitalis purpurea 9X

    Melilotus officinalis 4X

    Glonoinum 6X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Relief of Headache & Migraine Pain, Dizziness and Throbbing

  • USES

    This is a natural Homeopathic remedy that relieves headache and migraine pain, dizziness and throbbing.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 or 4 pellets to dissolve in mouth three times a day.

    Children under 12: Take 1/2 the adult dose.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • Package Labeling:

    Inner LabelNDC 60512-0018-1

  • INGREDIENTS AND APPEARANCE
    HEADACHE/MIGRAINE RELIEF 
    cyclamen europaeum, antimonium crudum, alumina, lycopodium clavatum, argentum nitricum, digitalis purpurea, melilotus officinalis, glonoinum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER4 [hp_X]
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE9 [hp_X]
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE9 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE5 [hp_X]
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE9 [hp_X]
    DIGITALIS PURPUREA WHOLE (UNII: UD4O8TY7RW) (DIGITALIS PURPUREA WHOLE - UNII:UD4O8TY7RW) DIGITALIS PURPUREA WHOLE9 [hp_X]
    MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP4 [hp_X]
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-0018-180 in 1 TUBE; Type 0: Not a Combination Product10/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-0018)
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