FDA records indicate that there are no current recalls for this drug.
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Fenoprofen Calcium Recall
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Questions & Answers
Side Effects & Adverse Reactions
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
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hives
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facial swelling
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shock
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asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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are age 60 or older
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have had stomach ulcers or bleeding problems
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take a blood thinning (anticoagulant) or steroid drug
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have 3 or more alcoholic drinks every day while using this product
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take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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take more or for a longer time than directed
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if you are allergic to aspirin or any other pain reliever/fever reducer
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for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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stomach bleeding warning applies to you
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you have a history of stomach problems, such as heartburn
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you have high blood pressure, heart disease, liver cirrhosis or kidney disease
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you have asthma
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you are taking a diuretic
taking a prescription drug for
- gout
- diabetes
- arthritis
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you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
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an allergic reaction occurs. Seek medical help right away.
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new symptoms occur
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ringing in the ears or loss of hearing occurs
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pain gets worse or lasts more than 10 days
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redness or swelling is present
These could be signs of a serious condition.
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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if you are allergic to aspirin or any other pain reliever/fever reducer
-
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
-
stomach bleeding warning applies to you
-
you have a history of stomach problems, such as heartburn
-
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
-
you have asthma
-
you are taking a diuretic
taking a prescription drug for
- gout
- diabetes
- arthritis
-
you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
-
an allergic reaction occurs. Seek medical help right away.
-
new symptoms occur
-
ringing in the ears or loss of hearing occurs
-
pain gets worse or lasts more than 10 days
-
redness or swelling is present
These could be signs of a serious condition.
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
for the temporary relief of minor aches and pains or as recommended by your doctor
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Fenoprofen Calcium Manufacturers
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Mylan Pharmaceuticals Inc.
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Pd-rx Pharmaceuticals, Inc.
Fenoprofen Calcium | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of fenoprofen calcium tablets and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with fenoprofen, the dose and frequency should be adjusted to suit an individual patient's needs.
AnalgesiaFor the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.
Rheumatoid Arthritis and OsteoarthritisFor the relief of rheumatoid arthritis or osteoarthritis the recommended dose is 300 mg to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3200 mg.
Fenoprofen calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished.
Patients with rheumatoid arthritis generally seem to require larger doses of fenoprofen calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed.
Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy.
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