Label: MIGRAIDE- cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet

  • NDC Code(s): 68466-2391-4
  • Packager: Schwabe Mexico, S.A. de C.V.
  • 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 November 9, 2021

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  • Active Ingredient

    Cimicifuga racemosa 3X

    Cyclamen europaeum 3X 
    Gelsemium sempervirens 3X
    Iris versicolor 2X
    Sanguinaria canadensis 3X

  • Inactive

    Cellulose

    Lactose Monohydrate
    Magnesium Stearate

  • Dosage & Administration

    Directions: Sublingual homeopathic medication.
    Place tablets under tongue at least 15 minutes before or half hour after eating, brushing teeth, or drinking anything except water.
    Adults and children 12 years of age and older: Take 3 tablets every hour until symptoms subside, then take 3 tablets every 2 hours until relieved.
    Children 6 to 12: Take 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved.
    Children under 2: Consult a doctor.

  • Purpose

    For the temporary relief of minor aches and pains associated with headaches or migraine headaches.

  • Indications & Usage

    For the temporary relief of minor aches and pains associated with headaches or migraine headaches.

  • Warnings

    Do not take this product for headache pain for more than 10 days (for adults) or 5 days (for children) unless directed by a doctor.

  • Stop Use

    Stop use and ask a doctor if pain persists or gets worse or if new symptoms occur.
    These could be signs of a serious condition.

  • Pregnacy or Breast Feeding

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

  • Keep out of reach of chiildren.

    Keep out of reach of chiildren.

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    21812390_Migraide_A02.jpg

  • INGREDIENTS AND APPEARANCE
    MIGRAIDE 
    cyclamen purpurascens tuber, black cohosh, iris versicolor whole, gelsemium sempervirens whole, sanguinaria canadensis root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-2391
    Route of AdministrationSUBLINGUAL, SUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER3 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]
    IRIS VERSICOLOR WHOLE (UNII: PYC571247P) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR WHOLE2 [hp_X]
    GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE3 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (B;T) Scoreno score
    ShapeROUND (B;T) Size8mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68466-2391-44 in 1 BOX07/02/201512/31/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/02/201512/31/2026
    Labeler - Schwabe Mexico, S.A. de C.V. (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-2391)
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