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.
Gluten FreeDISTRIBUTED BYMAJOR PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Greenville, SC 29605
Active Ingredient (In Each 5 Ml)
Ibuprofen 100 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
- Temporarily:relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothachereduces fever
- Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrash blistersIf 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 problemstakes a blood thinning (anticoagulant) or steroid drugtakes 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 reducerright before or after heart surgery
Ask A Doctor Before Use If
- Stomach bleeding warning applies to your childchild has a history of stomach problems, such as heartburnchild has problems or serious side effects from taking pain relievers or fever reducerschild has not been drinking fluidschild has lost a lot of fluid due to vomiting or diarrheachild has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a strokechild has asthmachild is taking a diuretic
Ask A Doctor Or Pharmacist Before Use If The Child Is
- Under a doctor's care for any serious conditiontaking 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 faintvomits bloodhas bloody or black stoolshas stomach pain that does not get betterchild has symptoms of heart problems or stroke:
- Chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingthe child does not get any relief within first day (24 hours) of treatmentfever or pain gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear
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)
- This product does not contain directions or complete warnings for adult usedo not give more than directed shake well before usingmL = milliliterfind right dose on chart. If possible, use weight to dose; otherwise use age.if needed repeat dose every
- 6–8 hoursdo not use more than
- 4 times a dayDosing ChartWeight (lb)Age (yr)Dose (mL)**or as directed by a doctorUnder 24 lbsunder 2 yearsask a doctor24–35 lbs2–3 years5 mL36–47 lbs4–5 years7.5 mL48–59 lbs6–8 years10 mL60–71 lbs9–10 years12.5 mL72–95 lbs11 years15 mL
- Each 5 mL contains: sodium 2 mg
- Store at 20° to 25°C (68° to 77°F)do not freezeChildren's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form:NDC 0121-1836-05:5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
Anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum.
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