"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
DOSAGE AND ADMINISTRATION
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. TESSALON (benzonatate) should be swallowed whole. TESSALON (benzonatate) Capsules and Perles are not to be broken, chewed, dissolved, cut or crushed.
Perles, 100 mg (yellow); bottles of 100 NDC 0069-0122-01 Imprint: T.
Perles, 100 mg (yellow); bottles of 500 NDC 0069-0122-02 Imprint: T
Capsules, 200 mg (yellow); bottles of 100 NDC 0069-0124-01 Imprint: 0698.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Rev. 12/15. Mfd by: Catalent Pharma Solutions St. Petersburg, Florida 33716. Pfizer Inc. Madison, New Jersey 07940
Prescribing Document Revised: January 2011This monograph has been modified to include the generic and brand name in many instances.
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