Chlorpheniramine and phenylephrine

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• chest pain, rapid pulse, fast or uneven heart rate;

• confusion, hallucinations, severe nervousness;

• tremor, seizure (convulsions);

• little or no urinating;

• easy bruising or bleeding, unusual weakness; or

• dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, shortness of breath).

Common side effects may include:

• dizziness, drowsiness, blurred vision;

• dry nose or mouth;

• nausea, stomach pain, constipation, loss of appetite;

• problems with memory or concentration; or

• feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

• Chlorpheniramine Maleate and Phenylephrine Hydrochloride
• Phenylephrine and Chlorpheniramine

• Alkylamine Derivative
• Alpha-Adrenergic Agonist
• Decongestant
• Histamine H1 Antagonist
• Histamine H1 Antagonist, First Generation

There are no dosage adjustments provided in the manufacturer’s labeling.

Some products may contain sodium.

See individual agents.

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and heart disease).

• Diabetes: Use with caution in patients with diabetes mellitus.

• GI obstruction: Use with caution in patients with GI obstruction.

• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Respiratory disease: Use with caution in patients with asthma or other chronic breathing disorders.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.

• Pediatric: Antihistamines may cause excitation in young children.

Dosage form specific issues:

• Tartrazine: Some products may contain tartrazine.

Other warnings/precautions:

• Self-medication (OTC use): When used for self medication (OTC), discontinue use and notify healthcare provider if new symptoms occur, if symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache or if nervousness, dizziness, or sleeplessness occur.

Animal reproduction studies have not been conducted with this combination. See individual agents.

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.