CHILDRENS IBUPROFEN- ibuprofen suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

7-Eleven

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug temporarily: - relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache - reduces fever - if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer - right before or after heart surgery - stomach bleeding warning applies to your child - child has a history of stomach problems, such as heartburn - child has problems or serious side effects from taking pain relievers or fever reducers - child has not been drinking fluids - child has lost a lot of fluid due to vomiting or diarrhea - child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke - child has asthma - child is taking a diuretic - under a doctor's care for any serious condition - taking any other drug - child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better - feels

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHILDRENS IBUPROFEN - IBUPROFEN SUSPENSION
7-ELEVEN
----------
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH 5 ML)_
Ibuprofen USP 100 mg (NSAID)*
_PURPOSE_
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
_USES_
temporarily:
relieves minor aches and pains due to the common cold, flu, sore
throat, headache
and toothache
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 your child:
has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs
(aspirin,
ibuprofen, naproxen, or others)
takes 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.
SORE THROAT WARNING: Severe or persistent sore throat or sore throat
accompanied by
high fever, headache, nausea, and vomiting may be serious. Consult
doctor promptly.
Do not use more than 2 days or administer to children under 3 years of
age unless
directed by doctor.
DO NOT USE
if the child has 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
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has problems or serious side effects from taking pain relievers
or fever
reducers
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, kidney
disea