DrugindexOnline^{2nd edition}

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, soo doe e FED rin)
Brand Names: Ambifed-G, Anatuss LA, Congestac, Decongest II, Defen-LA, Entex PSE, Eudal SR, Fenex-PSE, Guaibid D, Guaifed, Guaifenex PSE 60, Guaitab, Guaivent (Ethex), Guiatuss PE, Humibid GC, Iosal II, Nalex, Panmist LA, Poly-Vent, Respaire-60 SR, Robitussin PE, Ru Tuss DE, S-Pack, Sinufed, Sinutab Non Drying, Stamoist E, Syn-Rx, Touro LA, Tussin PE, Versacaps, Zephrex

What is S-Pack (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

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

The combination of guaifenesin and pseudoephedrine is used to treat nasal and sinus congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about S-Pack (guaifenesin and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.

What should I discuss with my healthcare provider before taking take S-Pack (guaifenesin and pseudoephedrine)?

Do not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or high blood pressure;

• diabetes; or

• a thyroid disorder.

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take S-Pack (guaifenesin and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a guaifenesin and pseudoephedrine overdose may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking S-Pack (guaifenesin and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.

S-Pack (guaifenesin and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• severe dizziness, anxiety, restless feeling, or nervousness;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Keep taking guaifenesin and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:

• dizziness or headache;

• feeling excited or restless;

• sleep problems (insomnia);

• nausea, vomiting, or stomach upset;

• mild loss of appetite;

• warmth, tingling, or redness under your skin; or

• skin rash or itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect S-Pack (guaifenesin and pseudoephedrine)?

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are using any of the following drugs:

• methyldopa (Aldomet);

• medicines to treat high blood pressure;

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

• antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

If you are using any of these drugs, you may not be able to use guaifenesin and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect guaifenesin and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has information about guaifenesin and pseudoephedrine written for health professionals that you may read.

What does my medication look like?

Guaifenesin and pseudoephedrine is available over-the-counter (without a prescription) under several brand and generic names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.02. Revision Date: 04/14/2007 5:42:39 PM.