STORAGE AND HANDLING SECTION.
Other information phenylketonurics: contains phenylalanine 6 mg per tablet store between 20-25C (68-77F) do not use if printed seal under cap is broken or missing
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-719-9260
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Compare to Childrens Motrin active ingredient for ages 2 to 11 childrens ibuprofen Chewable Tablets, 100 mg Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Chewables Chew or crush tablets completely before swallowing Orange Flavor actual size 24 ORANGE-FLAVORED TABLETS
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each chewable tablet) Ibuprofen 100 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 chew or crush tablets completely before swallowing this product does not contain directions or complete warnings for adult use do not give more than directed find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 48-59 6-8 2 60-71 9-10 2 72-95 11 3
INACTIVE INGREDIENT SECTION.
Inactive ingredients acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
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 mouth or throat burning may occur; give with food or water take 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