ADVIL MIGRAINE - ibuprofen capsule, liquid filled
Wyeth Consumer Healthcare

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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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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
a headache that is different from your usual migraines
the worst headache of your life
fever and stiff neck
headaches beginning after or caused by head injury, exertion, coughing or bending
experienced your first headache after the age of 50
daily headaches
a migraine so severe as to require bed rest
problems or serious side effects from taking pain relievers or fever reducers
stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
high blood pressure
heart or kidney disease
asthma
taken a diuretic
reached age 60 or older

Ask a doctor or pharmacist before use if you are

taking any other drug containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
migraine headache pain is not relieved or gets worse after first dose
stomach pain or upset gets worse or lasts
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 warnings and directions 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

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

U.S. Patent Nos. 5,071,643 and 5,360,615

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

ADVIL MIGRAINE
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0573-0168
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ibuprofen (ibuprofen)	ibuprofen	200 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (translucent brown)	Score	no score
Shape	OVAL (soft gelatin capsule)	Size	17mm
Flavor		Imprint Code	Advil
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0573-0168-20	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		20 CAPSULE In 1 BOTTLE	This package is contained within the CARTON (0573-0168-20)
2	0573-0168-30	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		40 CAPSULE In 1 BOTTLE	This package is contained within the CARTON (0573-0168-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020402	03/16/2000

Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 06/2009Wyeth Consumer Healthcare