MOTRIN IB- ibuprofen tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)

Available from:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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 - headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces fever

Authorization status:

New Drug Application

Summary of Product characteristics

MOTRIN IB- IBUPROFEN TABLET, FILM COATED
JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION
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MOTRIN IB
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH CAPLET)
Ibuprofen 200 mg (NSAID)
1
PURPOS E
Pain reliever/fever reducer
US ES
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
®
1
nonsteroidal anti-inflammatory drug
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
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
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, or
kidney disease
you have asthma
you are taking a diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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
WHEN USING THIS PRODUCT
take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than
dire