Label: MIGRANADE- chamomilla, natrum sulphuricum, sanguinaria canadensis, glutathione spray

  • 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, 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

    For nasal use only

  • Ask a doctor before use if you have

    •
    ear, nose or throat sensitivity
    •
    susceptibility to nose bleeds
  • When using this product

    •
    Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.
    •
    The use of this container by more than one person may spread infection.
  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    For best results, use at the first sign of migraine headache
    •
    Adults and children 6 years of age and older (with adult supervision):
    o
    Remove cap & safety clip (also see illustration on side carton & insert).
    o
    Hold with thumb at bottom of bottle and nozzle between your fingers.
    o
    Before using the first time, prime pump by depressing several times.
    o
    Place tip o nozzle just past nasal opening (approximately 1/8”).
    o
    Pump one to two times into each nostril.
    o
    Use as needed every four hours not exceed three times per 24 hours. If headache persists for more than 48 hours, consult a physician.
    •
    Children under 6 years of age: Consult a doctor before use.
  • Inactive Ingredients

    benzalkonium chloride, glycerin, hydroxyethylcellulose, methylparaben, potassium phosphate monobasic, purified water, sodium chloride, sodium phosphate dibasic

  • SPL UNCLASSIFIED SECTION

    Take at the first sign of migraine headache

    No known drug interactions
    Non-drowsy
    No jitters
    Non-habit forming
    Homeopathic

    Store at room temperature 15°C-29C-29°C (59°F-84°F)
    www.migranade.com
    Manufactured for Migranade, Inc.
    1450 2nd St.
    Santa Monica, California 90401-2302
    United States
    tel: 3104398674

    Product of USA Homeopathic

  • Patient Information

    Migranade Migraine Relief
    Non-Drowsy

    Relief of Migraine Headache

    Homeopathic

    DIRECTIONS: Adults and children 6 years of age and older (with adult supervision):

    1. Remove cap and safety clip.

    		Directions 1 and 2

    2. Hold with thumb at bottom of bottle and nozzle between your fingers.

    3. Before using the first time, prime pump by depressing several times.

    		Directions 3 to 5

    4. Place tip of nozzle just past nasal opening (approximately 1/8”).

    5. Pump one to two times into each nostril.

    6. Use as needed every four hours not to exceed three times per 24 hours. if headache persists for more than 48 hours, consult a physician.

    		Direction 6

    Children under 6 years of age: Consult a doctor before use.

    Active Ingredients:
    Chamomilla 3C,
    Natrum Sulphuricum 3C,
    Sanguinaria Canadensis 3C,
    Glutathione 1C

    Inactive Ingredients:
    benzalkonium chloride, glycerin, hydroxyethylcellulose, methlyparaben, potassium phosphate monobasic, purified water, sodium chloride, sodium phosphate dibasic

    Warnings:
    For nasal use only
    Ask a doctor before use if you have

    ear, nose or throat sensitivity
    susceptibility to nose bleeds

    When using this product

    Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.
    The use of this container by more than one person may spread infection.

    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. If swallowed, get medical help or contact a Poison Control Center right away.

    Take at the first sign of migraine headache.

    Migranade Migraine Relief

    •
    No known drug interactions
    •
    Non-drowsy
    •
    No jitters
    •
    Non-habit forming
    •
    Homeopathic

    Product is naturally dark in color.

     
    www.migranade.com

    Manufactured for:
    Migranade Inc.
    Santa Monica, California
    90401-2302
    United States
    tel:3104398674

     
    PRODUCT OF USA
     
    Homeopathic
  • Package/Label Principal Display Panel

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    MIGRANADE 
    chamomilla, natrum sulphuricum, sanguinaria canadensis, glutathione spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60916-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_C]  in 15 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE3 [hp_C]  in 15 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_C]  in 15 mL
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE1 [hp_C]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60916-001-011 in 1 CARTON
    115 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic01/27/2014
    Labeler - Migranade Inc. (079159028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oasis Health Products, Inc.964858315MANUFACTURE(60916-001)
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