Migranade
FDA Label NDC 60916-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Migranade Inc. for the product Migranade (NDC 60916-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

Directions 1 And 2 (4d28d68d 0793 4f45 9dbf Ce38cede000c 01)

Directions 1 And 2 (4d28d68d 0793 4f45 9dbf Ce38cede000c 01)

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 (4d28d68d 0793 4f45 9dbf Ce38cede000c 02)

Directions 3 To 5 (4d28d68d 0793 4f45 9dbf Ce38cede000c 02)

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 (4d28d68d 0793 4f45 9dbf Ce38cede000c 03)

Direction 6 (4d28d68d 0793 4f45 9dbf Ce38cede000c 03)

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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