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 = 1 teaspoonful)Ibuprofen 100mg (NSAID)**nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose: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 a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:■ hives■ shock■ asthma (wheezing)■ rash■ skin reddening■ blisters■ facial swellingIf 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 the child:■ has had stomach ulcers or bleeding problems■ takes a blood thinning (anticoagulant) or steroid drug■ takes other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or Other)■ takes more or for a longer time than directedSore 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.
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■ chid 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, or kidney disease■ child has asthma■ child is taking a diureticAsk a doctor or pharmacist before use if the child is■ under a doctor’s care for any serious condition■ taking any other drugWhen using this product■ 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.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■ 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
Otc - Do Not Use
Do not use■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer■ right before or after heart surgery
Otc - Keep Out Of Reach Of Children
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)
Dosage & Administration
Directions■ this product does not contain directions or complete warnings for adult use■ do not give more than directed■ mL= milliliter; tsp=teaspoonful■ shake well before using■ find right dose on chart. If possible, use weight to dose; otherwise use age.■ use only enclosed dosing syringe or cup■ if needed, repeat dose every 6-8 hours■ do not use more than 4 times a day■ replace original bottle cap to maintain child resistance Dosing ChartWeight (lb)Age (yr)Dose (tsp or mL)*under 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL (1 tsp)36-47 lbs4-5 years7.5 mL (1 ⅟2 tsp)48-59 lbs6-8 years10 mL (2 tsp)60-71 lbs9-10 years12.5 mL (2 ⅟2 tsp)72-95 lbs11 years15 mL (3 tsp)*or as directed by a doctor
Other Safety Information
Other information■ each 5 mL (1tsp) contains: sodium 1.755 mg■do not use if bottle cap seal is broken■ store between 68-77°F (20-25°C)■ see bottom panel for lot number and expiration date
Inactive Ingredients:Aspartame, Citric Acid, FD&C Yellow 6, Flavor, Polysorbate 80, Potassium Sorbate, Silicon Dioxide, Sodium Benzoate, Sodium Saccharin, Sorbitol, Sucrose, Water, Xanthan Gum
Otc - Questions
Questions or Comments?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
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