Applies to pseudoephedrine / triprolidine: oral liquid, oral tablet.

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.

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.
• Feeling sleepy.

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 pseudoephedrine/triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release.

Nervous system

Rare (less than 0.1%): Hallucinations

Frequency not reported: Central nervous system depression or excitation, drowsiness, sleep disturbance^[Ref]

Cardiovascular

Frequency not reported: Tachycardia^[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, nose and throat^[Ref]

Genitourinary

Frequency not reported: Urinary retention^[Ref]

Dermatologic

Frequency not reported: Skin rashes (with or without irritation)^[Ref]