IBUPROFEN PAIN RELIEVER/ FEVER REDUCER- ibuprofen suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/ fever reducer 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 any other pain reliever/fever reducer ■ right before or after heart surgery ■ 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 ■ the child does not get any relief within the first day (24 hours) of treatment ■ fever or pain gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER- IBUPROFEN SUSPENSION
AMNEAL PHARMACEUTICALS
----------
IBUPROFEN ORAL SUSPENSION, USP (NSAID)
PAIN RELIEVER/ FEVER REDUCER
100 MG/ 5 ML
OTC - ACTIVE INGREDIENT
_ACTIVE INGREDIENT _
_(IN EACH 5 ML = 1 TEASPOON)_
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE
_PURPOSE_
Pain reliever/ fever reducer
INDICATIONS AND USAGE
_USES_
Temporarily:
WARNINGS
_WARNINGS_
ALLERGY ALERT:
Ibuprofen may cause a severe allergic reaction, especially in people
allergic to aspirin.
Symptoms may include:
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 chances are higher if your child:
■ Relieves minor aches and pains due to the common cold, flu, sore
throat, headache and
toothache
■ Reduces fever
■ hives ■ facial swelling
■ asthma (wheezing) ■ shock
■ skin reddening ■ rash ■ blisters
■ has had stomach ulcers or bleeding problems
■ takes a blood thinning (anticoagulant) or steroid drug
■ takes other drugs containing an NSAID (aspirin, ibuprofen,
naproxen, or others)
■ takes more or for a longer time 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.
OTC - DO NOT USE
DO NOT USE:
OTC - ASK DOCTOR
ASK A DOCTOR BEFORE USE IF:
OTC - ASK DOCTOR/PHARMACIST
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS:
OTC - WHEN USING
WHEN USING THIS PRODUCT:
OTC - STOP USE
STOP USE AND ASK A DOCTOR IF:
OTC - KEEP OUT OF REACH OF CHILDREN
■ if the child has ever had an allergic reaction to any other pain
reliever/fever reducer
■ right before or after heart surgery
■ child has problems or serious side effects from taking pain
relievers or fever reducers
■ sto