Oral route (Tablet;Syrup) Promethazine hydrochloride should not be used in pediatric patients less than 2 years old because of the potential for fatal respiratory depression. Browse an A-Z list of Brand and Generic drugs to learn about your prescription medication. Reviews and ratings for promethazine. 218 reviews submitted with a 7.9 average score. Want more? Check out the Top 300 Drug List for a more extensive list of the most common outpatient medications in the U.S. market. What is the ClinCalc DrugStats Database? Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act) to notify FDA of a permanent discontinuance of certain drug products, six months in advance, or if that is not possible, as soon as practicable. Promethazine is a first-generation antihistamine. It is used to treat allergies, trouble sleeping, and nausea. It may help with some symptoms associated with the common cold. It may also be used for sedating people who are agitated or anxious. The safety and efficacy of bupropion for smoking cessation is not established in children or adolescents. Children 6 years and older with a major depressive episode or attention-deficit hyperactivity disorder (ADHD) have been studied in clinical trials of bupropion, but data regarding pediatric safety are limited. Promethazine and Codeine - Clinical Pharmacology Mechanism of Action. Codeine. Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. In September 2009, the FDA required the manufactures of parenteral promethazine to include a boxed warning emphasizing the established risk of severe tissue necrosis, gangrene, or other tissue damage associated with the intravenous administration of the drug. Tetracaine Hydrochloride Injection, USP TheraTears® Contact Lens Comfort Drops [carmellose sodium (sodium carboxymethylcellulose)].