FDA Label for Migranade

View Indications, Usage & Precautions

Migranade Product Label

The following document was submitted to the FDA by the labeler of this product Migranade Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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):
    • oRemove cap & safety clip (also see illustration on side carton & insert).
    • oHold with thumb at bottom of bottle and nozzle between your fingers.
    • oBefore using the first time, prime pump by depressing several times.
    • oPlace tip o nozzle just past nasal opening (approximately 1/8”).
    • oPump one to two times into each nostril.
    • oUse 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


Other



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.

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.

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.

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

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