ADVIL MIGRAINE

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0168

ADVIL MIGRAINE (ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH BROWN OVAL CAPSULE)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USE
  • treats migraine

WARNINGS

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if
  • you have never had migraines diagnosed by a health professional
  • you have a headache that is different from your usual migraines
  • you have the worst headache of your life
  • you have fever and stiff neck
  • you have headaches beginning after or caused by head injury, exertion, coughing or bending
  • you have experienced your first headache after the age of 50
  • you have daily headaches
  • you have a migraine so severe as to require bed rest
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • migraine headache pain is not relieved or gets worse after the first dose
  • any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS
  • do not take more than directed
  • the smallest effective dose should be used

adults
  • take 2 capsules with a glass of water
  • if symptoms persist of worsen, ask your doctor
  • do not take more than 2 capsules in 24 hours, unless directed by a doctor
under 18 years of age
  • ask a doctor

OTHER INFORMATION
  • each capsule contains: potassium 20 mg
  • read all directions and warnings before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

QUESTIONS OR COMMENTS?

Call toll-free 1-800-88-ADVIL

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Label

Advil®
MIGRAINE

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever (NSAID)

40 Liquid Filled
Capsules

Liquid Filled
Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Carton

Advil®
MIGRAINE
Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever (NSAID)

40 Liquid Filled Capsules

Liquid Filled
Capsules

ADVIL MIGRAINE 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0168
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
GELATIN 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBROWN (translucent brown) Scoreno score
ShapeOVAL (soft gelatin capsule) Size17mm
FlavorImprint CodeAdvil
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0168-201 BOTTLE in 1 CARTON
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:0573-0168-301 BOTTLE in 1 CARTON
240 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:0573-0168-401 BOTTLE in 1 CARTON
380 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040203/16/2000
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0168), MANUFACTURE(0573-0168), PACK(0573-0168), REPACK(0573-0168)

Revised: 05/2014
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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