guaifenesin/phenylephrine/phenylpropanolamine Health Article

Generic name(s):

guaifenesin/phenylephrine/phenylpropanolamine

Brand name(s):

guaifenesin/phenylephrine/PPA, Ami-Tex, Banex, Dura-Gest, Duratex, Enomine, Entex, Fentex, Guaifenex, Phenylfenesin, Quintex

What is the most important information I should know about guaifenesin/phenylephrine/phenylpropanolamine?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

What is guaifenesin/phenylephrine/phenylpropanolamine?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to ease breathing. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose, and throat), and increases the removal of mucous.

Phenylpropanolamine and phenylephrine are decongestants. They constrict (shrink) blood vessels (veins and arteries), which reduces the swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin/phenylephrine/phenylpropanolamine is used to treat the symptoms of the common cold and of infections of your sinuses, your lungs, and your throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin/phenylephrine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

Who should not take guaifenesin/phenylephrine/phenylpropanolamine?

Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• high blood pressure or any other type of heart disease,

• diabetes,

• a peripheral vascular disorder (poor circulation),

• glaucoma or increased pressure in the eyes,

• an overactive thyroid, or

• difficulty urinating or an enlarged prostate.

You may not be able to take guaifenesin/phenylephrine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin/phenylephrine/phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin/phenylephrine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Guaifenesin/phenylephrine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin/phenylephrine/phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin/phenylephrine/phenylpropanolamine has not been approved for use by children younger than 6 years of age.