Bayer Children's

For all patients taking this medicine (Bayer Children's):

• If you have an allergy to aspirin or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Asthma, bleeding problems, nose polyps, or rhinitis.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have a stomach or bowel ulcer.
• If you are more than 24 weeks pregnant.
• If you are taking another drug that has the same drug in it.
• If you are taking any other NSAID.

Children:

• If your child has or is getting better from flu signs, chickenpox, or other viral infections.

This is not a list of all drugs or health problems that interact with this medicine (Bayer Children's).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Feeling confused.
• Very bad headache.
• Ringing in ears.
• Hearing loss.
• Very bad belly pain.
• Feeling agitated.
• Seizures.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (Bayer Children's), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (Bayer Children's). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (Bayer Children's).

Review Date: October 4, 2017

Applies to aspirin: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, oral gum, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release, rectal suppository

Gastrointestinal

Common (1% to 10%): Dyspepsia,
Frequency not reported: GI bleeding, ulceration, perforation, nausea, vomiting, pancreatitis, gastric irritation, GI erosions, gastritis, melena, hematemesis, gingival bleeding[Ref]

Renal

Frequency not reported: Interstitial nephritis, papillary necrosis, renal insufficiency and failure[Ref]

Hematologic

Common (1% to 10%): Increased bleeding tendencies
Rare (0.01% to 0.1%): Aplastic anemia agranulocytosis, thrombocytopenia
Frequency not reported: Prolongation of prothrombin time, disseminated intravascular coagulation, coagulopathy, antepartum and postpartum bleeding, anemia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions including shock
Frequency not reported: Urticaria, angioedema, skin rashes[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Steven-Johnson syndrome, Lyell's syndrome, erythema nodosum, erythema multiforme
Frequency not reported: Purpura, hives[Ref]

Hepatic

Frequency not reported: Transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, hepatic insufficiency[Ref]

Metabolic

Frequency not reported: Thirst, dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis, hypoglycemia, hyperglycemia, hyperuricemia, salt and water retention[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hemorrhagic vasculitis
Frequency not reported: Dysrhythmias, hypotension, tachycardia[Ref]

Nervous system

Frequency not reported: Cerebral edema, coma headache, subdural or intracranial hemorrhage, seizures, lethargy, dizziness[Ref]

Other

Frequency not reported: Fever, hypothermia, hearing loss, tinnitus (at high doses), hearing disturbances[Ref]

Musculoskeletal

Frequency not reported: Rhabdomyolysis[Ref]

Respiratory

Frequency not reported: Hyperpnea, pulmonary edema, tachypnea, epistaxis, dyspnea, bronchospasm, asthma[Ref]

General

The more commonly experienced adverse effects include indigestion, dyspepsia, bleeding, and bruising.[Ref]

Genitourinary

Rare (0.01% to 0.1%): Menorrhagia
Frequency not reported: Proteinuria[Ref]

Psychiatric

Frequency not reported: Agitation, confusion[Ref]

Some side effects of Bayer Children's Aspirin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.