The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient(in each 5 mL)Ibuprofen 100 mg (NSAlD)**nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposeIbuprofen .... Pain reliever/fever reducer
Indications & Usage
Uses temporarily:■ relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache■ reduces fever
WarningsAllergy alert: Ibuprofen may cause asevere allergicreaction, especially In people allergic to aspirin. Symptomsmay include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blistersIf an allergic reaction occurs, stop use and seek medicalhelp right away.Stomach bleeding warning: This product contains anNSAID, which may cause severe stomach bleeding. Thechance 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 directedHeart attack and stroke warning: NSAIDs, exceptaspirin, increase the risk of heart attack, heart failure, andstroke. These can be fatal. The risk is higher if you usemore than directed or for longer than directed.Sore throat warning: Severe or persistent sore throat orsore throat accompanied by high fever, headache, nausea,and vomiting may be serious. Consult doctor promptly. Donot use more than 2 days or administer to children under 3years of age unless directed by doctor.
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is■ under a doctor's care for any serious condition■ taking any other drug
Otc - When Using
When using this product■ take with food or milk if stomach upset occurs
Otc - Stop Use
Stop use and ask a doctor if■ child experiences any of the following signs ofstomach 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, getmedical help or contact a Poison Control Center rightaway. (1-800-222-1222)
Dosage & Administration
Directions■ this product does not contain directions orcomplete warnings for adult use■ do not give more than directed■ shake well before using■ mL = milliliter■ find right dose on chart. If possible, use weight todose; otherwise use age.■ use only enclosed dosing cup. Do not use any otherdosing device.■ if needed, repeat dose every 6-8 hours■ do not use more than 4 times a day■ replace original bottle cap to maintain child resistanceDosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11years 15 mL* or as directed by a doctor
Other Safety Information
Other information■ each 5 mL contains: sodium 2 mg■ store between 20-25ºC (68-77ºF)■ do not use if carton is opened or printed bottle neckband is broken or missing■ see bottom panel for lot number and expiration date
Inactive ingredientsAcesulfame potassium, anhydrous citric acid,carboxymethylcellulose sodium, D&C Yellow #10, FD&CRed #40, flavors, glycerin, microcrystalline cellulose,polysorbate 80, propylene glycol, purified water, sodiumbenzoate, sucrose, and xanthan gum
Otc - Questions
Questions or comments?Call 732-314-4550 from 9AM to SPM EST,Monday - Friday.
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