Active ingredient (in each brown tablet)
Ibuprofen USP,
200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
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- temporarily relieves minor aches and pains due to:
• headache
• toothache
• backache
• menstrual cramps
• the common cold
• muscular aches
• minor pain of arthritis
- temporarily reduces fever
Warnings
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See carton for complete warnings (short label only)
See vial card for complete warnings (vial label only)
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
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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,
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and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
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• 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
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• 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
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• 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
Stop use and ask a doctor if
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- 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
Directions
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-
do not take more than directed
-
the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 tablet, 2 tablets may be used
• do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING (short label only)
-
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN (blister package only)
- store between 20˚-25˚C (68˚-77˚F)
- avoid excessive heat 40˚C (104˚F)
- see end flap for expiration date and lot number (carton only)
- use by expiration date on package (vial card, vial label & label only)
Inactive ingredients
carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose
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anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide
