Sudafed

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

No information provided.

Read the entire FDA prescribing information for Sudafed (Pseudoephedrine)

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Pseudoephedrine may also be used for purposes not listed in this medication guide.

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.

• Tell all of your health care providers that you take Sudafed. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Sudafed affects you.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine may cause nervousness, shakiness, and a fast heartbeat.
• Different brands of Sudafed may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sudafed while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.
• Not able to sleep.

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.

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 Sudafed Congestion may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.