TYLENOL COLD-FLU SEVERE (Brand for MUCINEX FAST-MAX COLD-FLU)

Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication increases the risk of liver injury. Contact your care team right away if you experience right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, or unusual weakness or fatigue.

· Notes for Professionals: The risk of developing hepatotoxicity from acetaminophen appears to be increased in patients who regularly consume alcohol. Patients who drink more than 3 alcohol-containing drinks a day and take acetaminophen are at increased risk of developing hepatotoxicity. Acute or chronic alcohol use increases acetaminophen-induced hepatotoxicity by inducing CYP2E1 leading to increased formation of the hepatotoxic metabolite of acetaminophen. Also, chronic alcohol use can deplete liver glutathione stores. Administration of acetaminophen should be limited or avoided altogether in patients with alcoholism or patients who consume alcohol regularly.

Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg, Oral tablet

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Grapefruit juice may increase the actions of Dextromethorphan, which may make some people feel drowsiness or other side effects (dizziness, nervousness or restlessness, nausea, vomiting, stomach upset) of Dextromethorphan that do not usually occur with prescribed or nonprescription product doses. It may be best to limit intake of grapefruit juice while you are taking Dextromethorphan-containing products.

· Notes for Professionals: Intake of grapefruit juice or seville orange juice increased dextromethorphan bioavailability in one study. Patients with increased concentrations of dextromethorphan may experience drowsiness or serotonergic side effects (dizziness, nervousness or restlessness, nausea, vomiting, stomach upset) not usually noted with prescribed or nonprescription product doses. Grapefruit juice and seville orange juice contain compounds that can inhibit P-glycoprotein in the intestinal wall, and dextromethorphan absorption may be affected by P-glycoprotein activity. Dextromethorphan is largely metabolized by CYP2D6, so this particular interaction with grapefruit juice may be more relevant in patients who are poor CYP2D6 metabolizers.

Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg, Oral tablet

Caffeine-containing Foods/Beverages

· Severity: Moderate

· Notes for Consumers: Limit caffeine intake (examples: coffee, teas, colas, chocolate and some herbal supplements) while taking Phenylephrine. Also avoid medicines containing additional Caffeine whenever possible. Side effects from Phenylephrine may get worse if you take excessive Caffeine. Taking a high amount of Caffeine can increase the risk of nausea, nervousness, palpitations, problems with sleep, rapid heartbeat, tremor, or other side effects.

· Notes for Professionals: Caffeine is a CNS-stimulant and such actions are expected to be additive when coadministered with other CNS stimulants or psychostimulants.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>