ElixSure Congestion

• It is used to treat nose stuffiness.

• If you have an allergy to pseudoephedrine or any other part of ElixSure Congestion (pseudoephedrine gel syrup).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with ElixSure Congestion.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take ElixSure Congestion. 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 ElixSure Congestion 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.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ElixSure Congestion while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.
• Measure liquid doses carefully. Use the measuring device that comes with ElixSure Congestion. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

• If you take ElixSure Congestion 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.

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