Infants Ibuprofen

Actavis Inc.

FULL PRESCRIBING INFORMATION

(in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

temporarily:

• reduces fever
• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 a NSAID, which may cause severe stomach bleeding. The chance is higher if the 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

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.

• if the child has ever had an allergic reaction to 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 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, or kidney disease
• child is taking a diuretic

• under a doctor’s care for any serious condition
• taking any other drug

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088
• 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• find right dose on chart below.  If possible, use weight to dose; otherwise use age.
• measure with the dosing device provided. Do not use with any other device.
• dispense liquid slowly into the child’s mouth, toward the inner cheek
• if needed, repeat dose every 6 to 8 hours
• do not use more than 4 times a day

Other information

• store between 20 to 25°C (68 to 77°F)
• do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing
• see bottom panel for lot number and expiration date

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline celullose, natural and artificial berry fruit punch type flavor, polysorbate-80, purified water, sodium benzoate, sorbitol solution, sucrose and xanthan gum.

1-800-432-8534 Monday  through Friday 9 am to 4 pm EST.

See New Warnings Information

Compare to the active ingredient in Concentrated Motrin( Infants’ Drops*

NDC 45963-125-24

For Ages 6 Mos. to 23 Mos.

Infants’ Ibuprofen

Concentrated Ibuprofen Oral Suspension, USP

(NSAID)

Pain Reliever

Fever Reducer

50 mg/1.25 mL

Lasts up to 8 hours

Use only with enclosed syringe

Non-Staining

Berry Flavor

Dye-Free

Alcohol Free

1 FL OZ (30 mL)