Advil Migraine

Generic Name: ibuprofen
Dosage Form: capsule, liquid filled

Advil Migraine (ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH BROWN OVAL CAPSULE)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

(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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil MIGRAINE

Solubilized Ibuprofen Capsules, 200 mg

Pain Reliever (NSAID)

40 Liquid Filled Capsules

Liquid Filled Capsules

See new warnings information

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Wyeth

For most recent product information, visit www.Advil.com

Distributed by: Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2009 Wyeth

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Advil Migraine 
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0168
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (translucent brown) Score no score
Shape OVAL (soft gelatin capsule) Size 17mm
Flavor Imprint Code Advil
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-0168-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 20 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2 NDC:0573-0168-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 40 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
3 NDC:0573-0168-32 1 BOTTLE (BOTTLE) in 1 CARTON
3 52 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020402 03/16/2000
Labeler - Pfizer Consumer Healthcare (828831730)
Revised: 06/2010
 
Pfizer Consumer Healthcare



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