PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel For Ages 6 to 23 mos. See New Warnings Infants' CONCENTRATED DROPS Ibuprofen Oral Suspension 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Lasts Up To 8 Hours No High Fructose Corn Syrup Use Only With Enclosed Syringe Berry Flavor Compare to active ingredient of Motrin Infants Drops 100% SATISFACTION GUARANTEED 0.5 FL OZ (15 mL)
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each 1.25 mL) Ibuprofen 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION.
Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
DOSAGE & ADMINISTRATION SECTION.
Directions 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. mL = milliliter measure with the dosing device provided. Do not use with any other device. dispense liquid slowly into the childs mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lbs) Age (mos) Dose (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 mos 1.875 mL
INACTIVE INGREDIENT SECTION.
Inactive ingredients anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
STORAGE AND HANDLING SECTION.
Other information store at 20-25C (68-77F) do not freeze do not use if printed neckband is broken or missing
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-719-9260
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 disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctors care for any serious condition taking any other drug When using this product give with food or milk if stomach upset occurs Stop use and ask a doctor if 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 child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
OTC - PURPOSE SECTION.
Purposes Pain reliever/fever reducer