Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel NDC 55154-1577-5 CHILDREN’S IBUPROFEN ORAL SUSPENSION 100 mg/5 mL 5 UNIT DOSE CUPS 100mg/5mL bag label
- Principal Display Panel NDC 55154-1577-5 CHILDREN’S IBUPROFEN ORAL SUSPENSION 100 mg/5 mL 5 UNIT DOSE CUPS 100mg/5mL bag label
Overview
Uses temporarily: ▪ relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache ▪ reduces fever
Indications & Usage
Uses temporarily: ▪ relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache ▪ reduces fever
Dosage & Administration
Directions ▪ Use as directed per healthcare professional. ▪ this product does not contain directions or complete 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 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) Dose (mL) or as directed by a doctor under 24 lbs 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 11 years 15 mL
Warnings & Precautions
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 doctor's 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)
Purpose
Purposes Pain reliever/fever reducer
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
When Using
When using this product ▪ give with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
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
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)
Storage & Handling
Other information ▪ each 5 mL contains: sodium 2 mg ▪ store at 20-25°C (68-77°F) ▪ do not freeze
Questions
Questions or comments? 1-800-397-9228
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