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The FDA has approved enhanced warning labels for
all over the counter non-steroidal
anti-inflammatory drug analgesics (NSAID),
including all Advil® products. These new labels
will provide consumers with more information about
potential cardiovascular, gastrointestinal and
allergic risks.
Products with revised labels should be in stores
by late 2006. In the meantime, we have posted the
revised label on this Web site. We continue to
work with the FDA to ensure the effective labeling
of our products.
Wyeth Consumer Healthcare stands firmly behind the
safety and effectiveness of Advil®. However, we
encourage all consumers to read the new, enhanced
Advil® labeling, with special attention to the
Warnings. All drugs, including those without a
prescription, must be used according to their
directions to be safe and effective.
Drug Facts
Solubilized ibuprofen equal to 200 mg
ibuprofen (NSAID)*
(present as the free acid and potassium salt) |
Pain reliever |
| *nonsteroidal
anti-inflammatory drug |
Uses:
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 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
long term continuous use may increase
the risk of heart attack or stroke
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
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adults
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- 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
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| under 18 years of age |
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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, sorbitans,
sorbitol
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