"A joint US Food and Drug Administration (FDA) advisory committee has recommended that a new immediate-release (IR) opioid analgesic be approved and that labeling describe the product as deterring abuse via intranasal (IN) and intravenous (IV) rou"...
Bayer Consumer (continued)
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, difficulty hearing, ringing in the ears, change in the amount of urine, persistent or severe nausea/vomiting, unexplained tiredness, dizziness, dark urine, yellowing eyes/skin.
This drug may rarely cause serious bleeding from the stomach/intestine or other areas of the body. If you notice any of the following rare but very serious side effects, seek immediate medical attention: black/tarry stools, persistent or severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body, sudden vision changes or severe headache.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Bayer (aspirin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking aspirin, tell your doctor or pharmacist if you are allergic to it; or to other salicylates (such as choline salicylate); or to other pain relievers or fever reducers (NSAIDs such as ibuprofen, naproxen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count).
If you have any of the following health problems, consult your doctor or pharmacist before using this medication: kidney disease, liver disease, diabetes, stomach problems (such as ulcers, heartburn, stomach pain), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), gout, certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this product, may increase your risk for this side effect. Limit alcoholic beverages, and stop smoking. Check with your doctor or pharmacist for more information.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness. Tell your doctor promptly if you see changes in behavior with nausea and vomiting. This may be an early sign of Reye's syndrome.
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and ulcers.
Aspirin is not recommended for use during pregnancy. Consult your doctor before using this medication if you are or think you may be pregnant. Tell your doctor immediately if you become pregnant while taking this medication. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery.
Aspirin passes into breast milk and may harm the nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional Bayer Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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