IBUPROFEN 100- ibuprofen tablet, coated IBUPROFEN 250- ibuprofen tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

JHK Inc dba American Safety & First Aid

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

pain reliever/fever reducer temporarily relieves fever and minor aches and pains associated with: - common cold - backache - headache - toothache - arthritis - muscular aches - menstrual cramps

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN 100- IBUPROFEN TABLET, COATED
IBUPROFEN 250- IBUPROFEN TABLET, COATED
JHK INC DBA AMERICAN SAFETY & FIRST AID
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IBUPROFEN
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLETS)
Ibuprofen, USP 200 mg (NSAID)
*Nonsteroidal Anti-Inflammatory Drug
PURPOSE
pain reliever/fever reducer
USE
temporarily relieves fever and minor aches and pains associated with:
common cold
backache
headache
toothache
arthritis
muscular aches
menstrual cramps
WARNINGS
ALLERGY ALERT
Ibuprofen may cause a severe allergic reaction, especially in people
allergic to aspirin.
Symptoms may include:
hives
asthma (wheezing)
facial swelling
shock
skin reddening
rash
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
severe stomach bleeding. The chance is higher if you:
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
DO NOT USE
if you 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 a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or
kidney disease
you are taking a diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking any other drug containing an NSAID (prescription or
nonprescription)
taking a blood thinning (anticoagulant) drug
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
long term continuous use may increase the risk of heart attack or
stroke
STOP USE AND ASK