IBUPROFEN- ibuprofen tablet, film coated
Preferred Pharmaceuticals, Inc.
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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Active ingredient (in each brown tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
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- temporarily relieves minor aches and pains due to:
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- toothache
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- the common cold
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- menstrual cramps
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- backache
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- headache
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- muscular aches
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- minor pain of arthritis
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- temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- facial swelling
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- hives
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- asthma (wheezing)
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- rash
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- shock
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- skin reddening
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- blister
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:
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- take more or for a longer time than directed
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- are age 60 or older
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- take a blood thinning (anticoagulant) or steroid drug
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- have had stomach ulcers or bleeding problems
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- have 3 or more alcoholic drinks every day while using this product
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.
Do not use
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- right before or after heart surgery
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if you have
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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- you are taking a diuretic
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- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
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- under a doctor"s care for any serious condition
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
When using this product
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- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- have bloody or black stools
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-
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- vomit blood
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- feel faint
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke
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- chest pain
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- slurred speech
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- leg swelling
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- trouble breathing
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- weakness in one part or side of body
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- 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 ( 1-800-222-1222) right away.
Directions
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-
do not take more than directed
-
-
the smallest effective dose should be used
- 1.
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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- if pain or fever does not respond to 1 tablet, 2 tablets may be used
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- do not exceed 6 tablets in 24 hours, unless directed by a doctor
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- children under 12 years: ask a doctor
Other information
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- use by expiration date on package
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- store between 20°-25°C (68°-77°F)
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- avoid excessive heat 40°C (104°F)
Inactive ingredients
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
Questions or comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 68788-9133
Compare to the active ingredient in Advil® Tablets†
Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg
Pain Reliever
Fever Reducer (NSAID)
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
Repackaged By: Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.