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This document summarizes important safety information regarding Advil Allergy and Congestion Relief. Please read carefully and consult your healthcare professional if you have any concerns.

• Stomach Bleeding Risk: This medication contains ibuprofen, which can increase the risk of stomach ulcers and bleeding. Immediate medical attention is necessary if you experience symptoms such as faintness, vomiting blood, dark stools, or severe abdominal pain. Those particularly at risk include individuals aged 60 and above, those with a history of stomach bleeding, or individuals taking aspirin, other NSAIDs, corticosteroids, blood thinners, or consuming three or more alcoholic drinks daily.

• Heart Attack and Stroke Risk: Ibuprofen can also elevate the risk of blood clots, potentially leading to heart attacks or strokes. It is recommended to use the lowest effective dose for the shortest duration. Avoid this medication if you have a history of heart problems or recent heart surgery. Seek emergency help if you encounter chest pain, shortness of breath, unilateral weakness, or difficulty speaking.

• Severe Allergic Reactions: Severe allergic reactions, including anaphylaxis, can occur. If you have allergies to aspirin or NSAIDs, inform your provider. Symptoms like hives, facial swelling, or breathing difficulties require immediate medical attention.

• Worsening of Medical Conditions: Use caution if you have pre-existing conditions such as liver or kidney disease, heart issues, high blood pressure, breathing difficulties, thyroid disease, diabetes, glaucoma, or urinary conditions, as this medication may exacerbate these issues.

• Accidental Overdose: The ingredients in this medication are found in many over-the-counter products. Using multiple products with the same components can lead to overdose and severe side effects, including kidney failure, seizures, and even death. Ensure your healthcare provider is aware of all medications you are taking.

• Potential Harm to Unborn Baby: If you are pregnant, consult your provider before using this medication. Phenylephrine may cause birth defects if taken in the first trimester, and ibuprofen can lead to complications if used during the second half of pregnancy.

Please carefully review medication labels and consult your healthcare provider or pharmacist if unsure whether a product contains an antihistamine, NSAID, or decongestant. In case of accidental overdose, seek immediate medical assistance or contact the poison control center at 1-800-222-1222.

Common side effects:

• Dizziness
• Sleepiness
• Constipation
• Upset stomach
• Heartburn
• Nausea
• Headache
• Dry mouth

Less common but important to monitor:

• Loss of appetite
• Swelling in the legs
• Skin rash
• Irregular heartbeat
• Sweating
• Changes in blood pressure

Serious side effects:

• Symptoms of a heart attack (chest pain or tightness, pain radiating to the shoulder, arm, neck, or jaw)
• Symptoms of a stroke (chest pain, breathing difficulties, weakness on one side of the body or face, slurred speech, leg swelling)
• Stomach bleeding (feeling faint, vomiting blood, having bloody or dark stools, experiencing severe stomach pain)
• Allergic reactions (hives, rash, blisters, swelling of the lips or tongue, difficulty breathing, skin reddening)

When taking Advil Allergy and Congestion Relief, it's important to be aware of potential interactions with other medications and substances:

• Other Antihistamines: Combining this medication with other antihistamines, such as diphenhydramine, can increase side effects like drowsiness, blurred vision, dry mouth, and difficulty urinating. These effects may be more pronounced in older adults.

• Decongestants: Using additional decongestants, like pseudoephedrine found in Sudafed, alongside this medication may elevate blood pressure and heart rate. This combination should be approached with caution, especially if you have a history of high blood pressure or heart disease.

• Alcohol: Consuming alcohol while taking this medication can intensify side effects such as dizziness, drowsiness, and difficulty concentrating. It's advisable to limit or avoid alcohol during treatment.

• Blood Pressure Medications: If you're on medications like Carvedilol for high blood pressure, combining them with this product may reduce the effectiveness of your blood pressure treatment. Consult your doctor before using them together.

• Monoamine Oxidase Inhibitors (MAOIs): Do not use this medication if you're currently taking or have recently stopped taking an MAOI, as this can lead to dangerous interactions.

Always inform your healthcare provider about all medications, supplements, and over-the-counter products you're using to ensure safe and effective treatment.