Sudafed 24 Hour

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• If you take Sudafed 24 Hour on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

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.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very nervous and excitable.
• Very bad headache.
• Very bad dizziness or passing out.
• Shortness of breath.
• Shakiness.
• Very bad belly pain.
• Very upset stomach or throwing up.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to pseudoephedrine: oral capsule, oral capsule extended release, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Along with its needed effects, pseudoephedrine (the active ingredient contained in Sudafed 24-Hour) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking pseudoephedrine:

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

Some side effects of pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nervousness
• restlessness
• trouble in sleeping

• Difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

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