Mucinex Fast-MAX Products: Recall - Incorrect Labeling

Including certain lots of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat

[Posted 04/22/2015]

AUDIENCE: Consumer

ISSUE: RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.

Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment.

BACKGROUND: RB is notifying its distributors and customers by direct correspondence. See the press release for a listing of affected product lot numbers.

RECOMMENDATION: RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:

Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;

Place the mixture in a container such as a sealed plastic bag; and

Throw the container in your household trash.

Consumers who have purchased this product can also contact the RB MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to www.mucinex.com/recall for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

[04/21/2015 - Press Release - RB]