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Advil Migraine

Package insert / prescribing information
Generic name: ibuprofen
Dosage form: capsule, liquid filled
Drug class: Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Sep 1, 2021.

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

Heart attack and stroke warning:

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Medication overuse headache warning:

Headaches may worsen if this product is used for 10 or more days per month.

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, asthma, or had a stroke
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

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
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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 at 20 weeks or later in 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 or 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, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions or Comments?

Call toll-free 1-800-88-ADVIL

Additional Information

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

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

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

Dist. by: GSK CH, Warren, NJ 07059 ©2021 GSK or licensor

Trademarks owned or licensed by GSK

PRINCIPAL DISPLAY PANEL

NDC 0573-0168-20

Advil
MIGRAINE

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever (NSAID)

20
Liquid Filled
Capsules

000068423 Front Carton

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
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C RED NO. 40
GELATIN, UNSPECIFIED
LIGHT MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL
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 in 1 CARTON
1 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
2 NDC:0573-0168-30 1 BOTTLE in 1 CARTON
2 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
3 NDC:0573-0168-40 1 BOTTLE in 1 CARTON
3 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020402 03/16/2000
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0168), LABEL(0573-0168), MANUFACTURE(0573-0168), PACK(0573-0168)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Frequently asked questions