FDA records indicate that there are no current recalls for this drug.
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Zicam Cold Remedy Vitality Soft Chews Recall
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Questions & Answers
Side Effects & Adverse Reactions
Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Salsalate contains a salicylate and therefore is not recommended for use in patients with chicken pox, influenza, or flu symptoms.
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
Carefully consider the potential benefits and risks of Salsalate Tablets and other treatment options before deciding to use Salsalate Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
History
There is currently no drug history available for this drug.
Other Information
Salsalate, is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxy-benzoic acid, 2-carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below.
Chemical Structure:
Inactive Ingredients: Hydroxypropylmethyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol.
Sources
Zicam Cold Remedy Vitality Soft Chews Manufacturers
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Matrixx Initiatives, Inc.
Zicam Cold Remedy Vitality Soft Chews | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of Salsalate Tablets and other treatment options before deciding to use Salsalate 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 Salsalate Tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
Adults: The usual dosage is 3000 mg daily, given in divided doses as follows:
1) two doses of two 750 mg tablets; 2) two doses of three 500 mg tablets; or 3) three doses of two 500 mg tablets. Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory.
Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady state. There is no evidence for development of tissue tolerance (tachyphylaxis), but salicylate therapy may induce increased activity of metabolizing liver enzymes, causing a greater rate of salicyluric acid production and excretion, with a resultant increase in dosage requirement for maintenance of therapeutic serum salicylate levels.
Children: Dosage recommendations and indications for salsalate use in children have not been established.
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