Label: HEADACHE AND MIGRAINE REAL RELIEF- cyclamen europaeum, antimonium crudum, alumina, lycopodium clavatum, alumina, lycopodium clavatum, argentum nitricum, digitalis purpurea, melilotus officinalis, glonoinum tablet, chewable

  • 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 October 25, 2012

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  • ACTIVE INGREDIENTS HPUS

    Cyclamen europaeum (Sowbread) 8X
    Antimonium crudum (Antimonous sulfide) 8X
    Alumina (Alumina) 8X
    Lycopodium clavatum (Clubmoss) 8X
    Argentum nitricum (Silver nitrate) 8X
    Digitalis purpurea (Foxglove) 8X
    Melilotus officinalis (Yellow sweet clover) 8X
    Glonoium (Glonoin) 8X

  • PURPOSE

    vertigo, dizziness, one-sided headache
    pain in forhead, nausea
    dizziness, vertigo, nausea
    throbbing pain and pain in temples
    headache from mental exhaustion
    head feels heavy
    vertigo, throbbing frontal headache
    snow-headache, sun-headache
  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    USES

    This homeopathic medicine helps relieve symptoms associated with headaches and migraines:

    - throbbing pain

    - dizziness

    - vertigo

    - nausea

  • WARNINGS


    Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

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

    Keep out of reach of children.

  • DIRECTIONS

    Chew tablets and let dissolve in mouth.

    Do not use more than directed.

    Do not take with food.

    Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


    Age
    		 Dose
    Adults and children 12 years of age and older2 tablets
    Children 6 to 11 years of age1 tablet
    Children under 6 years of ageAsk a doctor
  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    HEADACHE AND MIGRAINE  REAL RELIEF
    cyclamen europaeum, antimonium crudum, alumina, lycopodium clavatum, alumina, lycopodium clavatum, argentum nitricum, digitalis purpurea, melilotus officinalis, glonoinum tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER8 [hp_X]
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE8 [hp_X]
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE8 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE8 [hp_X]
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER CATION8 [hp_X]
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS8 [hp_X]
    MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP8 [hp_X]
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6031-090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/25/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6031)
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