Note: This document contains side effect information about acetaminophen / phenylephrine. Some dosage forms listed on this page may not apply to the brand name Mapap Sinus Congestion and Pain.

Applies to acetaminophen / phenylephrine: oral capsule.

Serious side effects

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• 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.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Other side effects

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:

• Dizziness.
• Feeling nervous and excitable.
• Trouble sleeping.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to acetaminophen/phenylephrine: oral capsule, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet effervescent.

Dermatologic

Very rare (less than 0.01%): Serious skin reactions

Frequency not reported: Skin rash^[Ref]

Hematologic

Frequency not reported: Thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis^[Ref]

Reports of blood dyscrasias are not necessarily causally related to acetaminophen.^[Ref]

Gastrointestinal

Frequency not reported: Abdominal discomfort, nausea, vomiting^[Ref]

Genitourinary

Frequency not reported: Urinary retention (especially in males)^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity^[Ref]