Label: MIGRANADE- chamomilla, natrum sulphuricum, sanguinaria canadensis, glutathione 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 August 1, 2014

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  • Active Ingredients

    Chamomilla 3C

    Natrum Sulphuricum 3C

    Sanguinaria Canadensis 3C

    Glutathione 1C

  • Purpose

    Migraine Relief

  • Uses

    For the treatment of pain associated with migraine headache.

  • Warnings

    •
    Tablets must be fully dissolved in water before taking.
    •
    Stop use and ask a doctor if symptoms persist.
    •
    If pregnant or breast feeding, ask a health professional before use.

    Keep Out of Reach of Children

    •
    Keep out of reach of children.
  • Directions

    •
    At the first sign of migraine headache, dissolve two tablets completely in 8 oz of room temperature water and drink at once.
    •
    For adults and children 6 years of age and older (with adult supervision)
    •
    Children under 6 years of age: Consult a doctor before use.
  • Inactive Ingredients

    sodium bicarbonate, ascorbic acid, n-acetyl l-cysteine, citric acid, microcrystalline cellulose, natural lemon flavor, magnesium citrate, natural lemonade flavor, sodium chloride, monkfruit

  • Principal Display Panel

    NDC 60916-002-02

    Migranade™

    Migraine Relief

    Relief of Migraine Headaches

    20 Effervescent Tablets

    Homeopathic

    TAKE AT THE FIRST SIGN OF MIGRAINE HEADACHE

    • Caffeine Free

    • Acetaminophen Free

    • Aspirin Free

    • Non-Drowsy

    • No Jitters

    • Non-Habit Forming

    Manufactured for Migranade, Inc.

    One World Trade Center, 8th Floor

    Long Beach, CA 90831

    www.migranade.com

    Store at room temperature 15°C-29C° (59F°-84°F)

    Product of USA

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    MIGRANADE 
    chamomilla, natrum sulphuricum, sanguinaria canadensis, glutathione tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60916-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_C]  in 3 g
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE3 [hp_C]  in 3 g
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_C]  in 3 g
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE1 [hp_C]  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM CITRATE (UNII: RHO26O1T9V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60916-002-0210 in 1 CARTON
    16.8 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic08/01/2014
    Labeler - Migranade Inc. (079159028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oasis Health Products, Inc.964858315MANUFACTURE(60916-002)
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