Aldex G

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

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

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

Guaifenesin and phenylephrine is a combination medicine used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

You should not use guaifenesin and phenylephrine if you are allergic to it.

Do not use guaifenesin and phenylephrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• high blood pressure, heart disease, coronary artery disease;

• diabetes;

• circulation problems;

• glaucoma;

• overactive thyroid; or

• enlarged prostate or problems with urination.

It is not known if this medication may be harmful to an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Guaifenesin and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug.

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.

Applies to guaifenesin / phenylephrine: oral capsule, oral capsule extended release, oral drops, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Nervous system

Nervous system side effects have included central nervous system depression, tremor, headache, dizziness, restlessness, insomnia, and convulsions.[Ref]

Psychiatric

Psychiatric side effects have included fear, nervousness, anxiety, and hallucinations.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Respiratory

Respiratory side effects have included breathing difficulty.[Ref]

Genitourinary

Genitourinary side effects have included dysuria.[Ref]

Dermatologic

Dermatologic side effects have included pallor.[Ref]

General

General side effects have included weakness.[Ref]

Some side effects of Aldex G may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available