IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER- ibuprofen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 200 mg

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER- IBUPROFEN TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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IBUPROFEN CAPLETS, USP
FEVER REDUCER/ PAIN RELIEVER (NSAID)
_DRUG FACTS_
_ACTIVE INGREDIENT _
_(IN EACH CAPLET)_
Ibuprofen USP, 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
_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
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 DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking aspirin for he