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# Web Page Misleads on Tuxarin: FDA
- URL: https://www.fdaweb.com/web-page-misleads-on-tuxarin-fda/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137580

CDER’s Office of Prescription Drug Promotion (OPDP) says that a Web page for Spriaso’s Tuxarin ER (codeine phosphate and chlorpheniramine maleate) extended release tablets makes false or misleading claims or representations about risks associated with the drug and inadequately communicates its full indication. “This Web page is concerning from a public health perspective because it creates a misleading impression about the safety and approved indication for Tuxarin ER,” OPDP says in a 12/13 [Warning Letter](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM533578.pdf?ref=fdaweb.com).

The letter says that Tuxarin ER is indicated for the relief of cough and symptoms associated with respiratory allergies or a common cold in adults age 18 and older. The labeling contains a Boxed Warning regarding respiratory depression and death which have occurred in children who received codeine following tonsillectomy and/or adenoidectomy. It is contraindicated in postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy, and in patients with known hypersensitivity to codeine, chlorpheniramine, or any of the product’s components. There also are Warnings and Precautions about death related to ultra-rapid metabolism of codeine to morphine, respiratory depression, drug dependence, head injury and increased intracranial pressure, activities requiring mental alertness, obstructive bowel disease, acute abdominal conditions, and use in special risk populations.

OPDP says the Web page fails to communicate any risk information about the product and contains claims that it considers misleading because they suggest that Tuxarin ER is safer than its competitors based on differences in dosage formulations and the safety profiles of individual ingredients. “No references were cited in support of these claims and we are not aware of evidence to support the suggestion that Tuxarin ER is safer than its competitors because of its tablet formulation or because it is not associated with ‘dosing errors’ or ‘serious safety issues,’” the letter says. “Such statements raise considerable public health concerns and are particularly alarming with respect to an opiate agonist product, as these controlled substances can lead to overdose, dependence, abuse, and death.”

OPDP also cites Web page claims that it says are misleading because they fail to adequately communicate the full approved indication for Tuxarin ER. In particular, it says, it fails to communicate that the approved indication is for adults and that it is not indicated for pediatric patients under age 18\. “This is particularly concerning given that Tuxarin ER has a Boxed Warning and a Contraindication regarding use in children, neither of which is disclosed on the Web page …,” the letter says.

Spriaso was told to immediately stop misbranding Tuxarin ER and to respond with a list of promotional materials containing presentations such as those in the letter and a plan for discontinuing their use. It also was told to develop a plan to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to audiences that received violative promotional materials.