IBUPROFEN- ibuprofen 200mg tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ADVANCED FIRST AID, INC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

pain reliever/fever reducer Uses: temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces fever

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN 200MG TABLET, FILM COATED
ADVANCED FIRST AID, INC.
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ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)
*nonsteroidal anti-inflammatory drug
pain reliever/fever reducer
Uses:
temporarily relieves minor aches and pains due to: • headache •
muscular aches • backache • minor pain
of arthritis • toothache • menstrual cramps • common cold •
temporarily reduces fever
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 • 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 prescription or non prescription 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 any other
pain reliever/fever reducer • right
before or after heart surgery
ASK A DOCTOR BEFORE USE IF: • 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 heart burn • 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: • taking aspirin
for heart attack or str