July 1, 2015 - The U.S. Food and Drug Administration (FDA) approved Tuxarin ER (codeine/chlorpheniramine), manufactured by Spriasco LLC and Nexgen Pharma, for the relief of the common cold, cough, and symptoms associated with upper respiratory allergies. Tuxarin ER uses the cough suppressant attributes of codeine and antihistamine properties of chlophreniramine, to provide a long lasting combination medication to reduce common cough and cold symptoms. The approved use is a twice-daily therapy in adults 18 years of age and older. Tuxarin ER tablets will be available as 54.3mg of codeine phosphate and 8mg of chlorpheniramine maleate.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.