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

Migranade by

Drug Labeling and Warnings

Migranade by is a Homeopathic medication manufactured, distributed, or labeled by Migranade Inc., Oasis Health Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
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

INGREDIENTS AND APPEARANCE

MIGRANADE 
chamomilla, natrum sulphuricum, sanguinaria canadensis, glutathione spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60916-001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	3 [hp_C]  in 15 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	3 [hp_C]  in 15 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_C]  in 15 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	1 [hp_C]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60916-001-01	1 in 1 CARTON
1		15 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		01/27/2014

Labeler - Migranade Inc. (079159028)

Establishment
Name	Address	ID/FEI	Business Operations
Oasis Health Products, Inc.		964858315	MANUFACTURE(60916-001)