Infants Ibuprofen

Kinray, 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 nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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.

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• not been drinking fluids
• lost a lot of fluid due to vomiting or diarrhea
• high blood pressure
• heart or kidney disease
• asthma
• taking a diuretic

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• 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
• the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
• stomach pain or upset gets worse or lasts
• 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 (1-800-222-1222) right away.

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• do not give longer than 10 days, unless directed by a doctor (see Warnings)
• 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

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

Preferred Plus ++++ Pharmacy

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

Berry Flavor

Dye-Free

• Alcohol Free
• Non-Staining

Use only with enclosed syringe

1 FL OZ (30 mL)

VC109115