IBUPROFEN tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

BETTER LIVING BRANDS LLC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever ■ if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer ■ right before or after heart surgery ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the 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 ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ■ under a doctor’s care for any serious condition ■ taking any other drug ■ 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, COATED
BETTER LIVING BRANDS LLC.
----------
IBUPROFEN
TABLETS USP, 200 MG
PAIN RELIEVER/FEVER REDUCER (NSAID)*
SEE NEW WARNINGS
ACTIVE INGREDIENT (IN EACH CAPLET)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever/fever reducer
USES
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ minor pain of arthritis
■ toothache
■ backache
■ the common cold
■ menstrual cramps
■ temporarily reduces fever
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.
DO NOT USE
■ if you have ever had an allergic reaction to ibuprofen or any
other pain reliever/fever
reducer
■ right before or after heart surgery
ASK A DOCTOR BEFORE USE IF
■ you have problems or serious side effects from taking pain
relievers or fever
reducers
■ the 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
ASK A DOCT