PAIN RELIEVER PLUS (Generic for EXCEDRIN MIGRAINE)

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg, Oral tablet

Caffeine-containing Foods/Beverages

· Severity: Moderate

· Notes for Consumers: While taking Caffeine-containing medicines, limit the use of foods, beverages (examples: coffee, tea, colas), herbs (examples: guarana, green tea) and other products that contain additional caffeine, such as chocolate and some non-prescription medications or dietary supplements for headache, insomnia, or weight loss. Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. Some drug products for adults that contain caffeine have about as much caffeine as a cup of coffee.

· Notes for Professionals: Certain foods that contain high amounts of caffeine or theobromine should be limited during the therapeutic use of caffeine in order to limit additive methylxanthine effects. While taking Caffeine-containing medicines, limit the use of foods, beverages (examples: coffee, tea, colas), herbs (examples: guarana, green tea) and other products that contain additional caffeine, such as chocolate and some non-prescription medications or dietary supplements for headache, insomnia, or weight loss. Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. Some drug products for adults that contain caffeine have about as much caffeine as a cup of coffee.

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Side effects from this drug may get worse if you drink alcohol-containing drinks. If you have persistent stomach upset, vomit blood or what looks like coffee grounds, or have black, tarry stools, contact your health care provider immediately. Avoid alcohol containing drinks while taking aspirin. Alcohol intake should be limited even with short term use of aspirin or related pain relievers.

· Notes for Professionals: Concomitant ingestion of ethanol with salicylates, especially aspirin, ASA, increases the risk of developing gastric irritation and GI mucosal bleeding. Ethanol and salicylates are mucosal irritants and aspirin decreases platelet aggregation. Routine ingestion of ethanol and aspirin can cause significant GI bleeding, which may or may not be overt. Even occasional concomitant use of salicylates and ethanol should be avoided. Chronic alcoholism is often associated with hypoprothrombinemia and this condition increases the risk of salicylate-induced bleeding. Patients should be warned regarding the potential for increased risk of GI bleeding if alcohol-containing beverages are taken concurrently with salicylates.

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg, Oral tablet

Tobacco

· Severity: Moderate

· Notes for Consumers: Tobacco smoke contains substances that may speed the removal of Caffeine from the body. If you start smoking Caffeine may become less effective. Tobacco smokers often drink several caffeinated beverages daily. Just the opposite occurs when someone stops smoking tobacco; if you stop smoking this may increase the amount of Caffeine in the blood and side effects from Caffeine may get worse. Too much Caffeine can cause nausea, nervousness, or sleeplessness, and occasionally other effects like tremor. If you stop smoking tobacco, you may need to lower your Caffeine intake.

· Notes for Professionals: Inducers of the hepatic CYP450 isoenzyme CYP1A2 may induce the hepatic oxidative metabolism of caffeine. Tobacco smoke contains hydrocarbons that induce hepatic CYP450 microsomal enzymes (e.g., CYP1A1, CYP1A2, CYP2E1). The increased clearance of caffeine by smokers may contribute to the higher consumption of caffeinated beverages reported to occur in this group. Because the effect on hepatic microsomal enzymes is not related to the nicotine component of tobacco, the sudden cessation of tobacco smoking may result in a reduced clearance of caffeine, despite the initiation of a nicotine replacement product. Following several days of abstinence from chronic tobacco smoking, caffeine clearance may decrease by roughly 40%, leading to the possible occurrence of caffeine-related side effects like nausea, nervousness, irritability, tremors, or insomnia, if caffeine use remains the same.

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg, Oral tablet

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Do not significantly alter your grapefruit juice intake while taking medicines containing caffeine. Some reports suggest that intake of grapefruit juice can increase side effects from caffeine. Too much Caffeine can cause effects like nausea, tremor, nervousness, or sleeplessness. If these occur, consider ingesting less caffeine daily.

· Notes for Professionals: Data are limited and conflicting as to whether grapefruit juice significantly alters the serum concentrations and/or AUC of caffeine. Caffeine is primarily a CYP1A2 substrate, and grapefruit juice appears to have but a small effect on this enzyme in vivo. One report suggests that grapefruit juice decreases caffeine elimination by inhibition of flavin-containing monooxygenase, a P450 independent system. This interaction might increase caffeine levels and mildly potentiate the clinical effects and common side effects of caffeine. If side effects appear, patients may need to limit either caffeine or grapefruit juice intake.

<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>