FDA records indicate that there are no current recalls for this drug.
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Concentrated Ibuprofen Suspension Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 a 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
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■ takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others).
■ takes more or for a longer time 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.
■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
Ask a doctor before use if (two bulleted items removed; child has asthma and child has problems and serious side effects etc)
■ stomach bleeding warning applies to your child
■ child has a history of stomach problems, such as heartburn
■ 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 is taking a diuretic
■ under a doctor’s care for any serious condition
■ taking any other drug
■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
■ 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 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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
temporarily:
■ reduces fever
■ relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Concentrated Ibuprofen Suspension Manufacturers
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Tris Phrama Inc
Concentrated Ibuprofen Suspension | Tris Phrama Inc
■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed
■ shake well before using
■ find right dose on chart below. If possible, use weight to dose; otherwise use age.
■ measure with the dosing device provided. Do not use with any other device.
■ dispense liquid slowly into the child’s mouth, toward the inner cheek
■ if needed, repeat dose every 6 to 8 hours
■ do not use more than 4 times a day
Dosing Chart Weight (lb) Age (mos) Dose (mL under 6 mos ask a doctor 12 to 17 lbs 6 to 11 mos 1.25 mL 18 to 23 lbs 12 to 23 mos 1.875 mLOther information
■ store between 20 to 25˚C (68 to 77˚F)
■ do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing
■ see bottom panel for lot number and expiration date
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