IBUPROFEN- ibuprofen tablet, film coated
Major Pharmaceuticals
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer
stomach bleeding warning applies to you
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
you have problems or serious side effects from taking pain relievers or fever reducers
you experience any of the following signs of stomach bleeding:
have bloody or black stools
feel faint
have stomach pain that does not get better
you have symptoms of heart problems or stroke
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
do not take more than directed
the smallest effective dose should be used
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
use by expiration date on package
store between 20°-25°C (68°-77°F)
avoid excessive heat 40°C (104°F)
carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide
MAJOR®
NDC 0904-7915-80
Compare to the active ingredient in Advil® Tablets†
Ibuprofen
Tablets
Ibuprofen Tablets USP, 200 mg
Pain Reliever
Fever Reducer (NSAID)
1000 COATED TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1116E29116
Distributed by
MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA M-17 Rev.09/17
Re-order No. 700643
Major 44-291
IBUPROFEN
ibuprofen tablet, film coated |
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Labeler - Major Pharmaceuticals (191427277) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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LNK International, Inc. | 832867894 | MANUFACTURE(0904-7915) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 038154464 | PACK(0904-7915) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 967626305 | PACK(0904-7915) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 832867837 | PACK(0904-7915) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 868734088 | PACK(0904-7915) |