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This document outlines crucial safety information and warnings associated with the use of Aleve PM (naproxen / diphenhydramine). It is essential to review this information thoroughly and consult your healthcare provider if you have any concerns or questions.

• Stomach Bleeding: Aleve PM contains naproxen, which can lead to the formation of ulcers in the stomach, potentially causing bleeding. This condition is serious and requires immediate medical attention. Inform your healthcare provider of all your current medications and medical conditions before starting Aleve PM. Be particularly cautious if you are taking aspirin, other NSAIDs, corticosteroids, or blood thinners, as these can increase bleeding risks. Seek medical help if you experience symptoms such as faintness, vomiting blood, bloody or dark stools, or persistent severe stomach pain. Risks are elevated for those over 60, with a history of bleeding problems, consuming three or more alcoholic drinks daily, or using Aleve PM long-term.

• Heart Attack and Stroke: The naproxen in Aleve PM can increase the risk of blood clots, potentially leading to heart attack or stroke. This risk is heightened for individuals with pre-existing heart conditions, those taking high doses, or using the medication over extended periods. Use the lowest effective dose for the shortest duration. Avoid Aleve PM if you have had or plan to have heart surgery. Immediately seek emergency help if you experience chest pain, shortness of breath, weakness on one side, or difficulty speaking. Risks include a history of heart issues, high doses, long-term use, or planned heart surgery.

• Worsening of Medical Conditions: Do not take Aleve PM if you have any risk factors without consulting your provider. This medication can exacerbate existing conditions and cause serious side effects. Disclose your full medical history to your healthcare provider before use. Risks include previous adverse reactions to pain relievers, stomach issues, respiratory problems, kidney or liver disease, cardiovascular conditions, glaucoma, or urinary disorders.

• Accidental Overdose: Aleve PM contains both naproxen and diphenhydramine, which are found in many over-the-counter products. Using multiple products with these ingredients can lead to an overdose, resulting in severe side effects such as kidney failure, seizures, hallucinations, daytime drowsiness, stomach bleeding, heart attack, stroke, or even death.

• Severe Allergic Reactions: Life-threatening allergic reactions to Aleve PM can occur, including facial swelling, shock, and anaphylaxis. Notify your provider if you have allergies to aspirin or other NSAIDs. If you experience symptoms like hives, rashes, swelling of lips or tongue, or difficulty breathing, seek immediate medical attention. Risks include allergies to aspirin or NSAIDs.

• Potential Harm to Unborn Baby: Avoid Aleve PM if you are at least 20 weeks pregnant, as naproxen can cause harm to the unborn baby or delivery complications. If you are pregnant, consult your healthcare provider to ensure safety before taking this medication.

Contraindications: Do not use Aleve PM if you have recently undergone or are planning to have heart surgery. Consult with your healthcare provider if any contraindications apply to you.

When taking this medication, you may encounter some common side effects, which are generally mild. These include sleepiness, dizziness, dry mouth, stomach upset, heartburn, nausea, and skin rashes. While these symptoms are typically not serious, it is advisable to consult your healthcare provider if they persist or become bothersome.

Additionally, there are other side effects that some users have reported. These include constipation, trouble urinating, kidney problems, blurry vision, and confusion. If you experience any of these effects, especially if they are severe, contacting your healthcare provider is recommended.

On rare occasions, serious side effects can occur, and they require immediate medical attention. These include symptoms of a heart attack, such as chest pain or tightness and pain radiating to your shoulder, arm, neck, or jaw. Signs of a stroke, like chest pain, trouble breathing, weakness in one part of your body or face, slurred speech, and leg swelling, should also be addressed urgently. Stomach bleeding, characterized by feeling faint, vomiting blood, bloody or dark stools, and severe stomach pain, is another critical concern. Lastly, allergic reactions like hives, rash, blisters, skin reddening, swelling of the lips or tongue, and difficulty breathing necessitate prompt medical care.