Drixoral Decongestant Non-Drowsy

Do not use pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Always ask a doctor before giving a cough or cold medicine to a child.

You should not use this medicine if you are allergic to pseudoephedrine.

Do not use pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if it is safe for you to use pseudoephedrine if you have other medical conditions, especially:

• heart disease or high blood pressure;

• enlarged prostate and urination problems;

• diabetes; or

• a thyroid disorder.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

It is not known whether pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Since pseudoephedrine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

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

• fast or pounding heartbeats;

• severe dizziness;

• severe nervousness; or

• sleep problems (insomnia).

Common side effects may include:

• feeling restless or nervous.

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.

Applies to pseudoephedrine: compounding powder, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet extended release

General

The most commonly reported adverse effects have included cardiovascular and (e.g. elevated blood pressure, tachycardia, or arrhythmias), CNS stimulation (e.g. restlessness, insomnia, anxiety, tremors, and rarely hallucinations), skin rashes, and urinary retention.[Ref]

Cardiovascular

Frequency not reported: Tachycardia, palpitations, arrhythmia, hypertension, impaired circulation to the extremities[Ref]

Nervous system

Frequency not reported: Headache, tremor

Gastrointestinal

Frequency not reported: Dry mouth, nausea, vomiting

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including cross-sensitivity with other sympathomimetic[Ref]

Psychiatric

Rare (less than 0.1%): Hallucinations
Frequency not reported: Restlessness, insomnia, sleep disturbances, anxiety, excitability[Ref]

Genitourinary

Frequency not reported: Urinary retention, especially in men with prostatic enlargement

Ocular

Frequency not reported: Angle-closure glaucoma

Dermatologic

Frequency not reported: Skin rashes, fixed drug eruption in the form of erythematous nodular patches[Ref]

Other

Post marketing reports: False-positive amphetamine immunoassay[Ref]

False-positives can occur far below the published threshold indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.[Ref]

Some side effects of Drixoral Decongestant Non-Drowsy may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.