Pseudovent 400 Capsules

DRUG DESCRIPTION

Each Pseudovent™ 400 (pseudoephedrine hcl extended-release and guaifenesin) 12-hour Capsule contains in combination:

Pseudoephedrine hydrochloride .......... 120 mg (extended-release)

Guaifenesin ........................ 400 mg (immediate-release to provide rapid action) in a formula to provide a prolonged and immediate release therapeutic effect

Pseudovent™ 400 (pseudoephedrine hcl extended-release and guaifenesin) also contains the following inactive ingredients: Black iron oxide, calcium stearate, D&C yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #3 aluminum lake, FD&C red #40 aluminum lake, gelatin, hypromellose, oleic acid, pharmaceutical glaze, polyethylene glycol, propylene glycol, red iron oxide, silica, sucrose, starch, talc and titanium dioxide.

Pseudoephedrine hydrochloride is an adrenergic (vasoconstrictor) agent having the chemical name benzenemethanol, ?-[1-(methylamino)ethyl]-, [S - (R*, R*)] -, hydrochloride.

Guaifenesin is an expectorant. Chemically, it is 3-(2- methoxyphenoxy)-1, 2-propanediol.

What are the precautions when taking pseudoephedrine hcl extended-release and guaifenesin (Pseudovent 400 Capsules)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a bad reaction to similar drugs (sympathomimetics such as ephedrine, phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus, high blood pressure, heart disease (such as chest pain, heart failure, heart attack), fast/slow/irregular heartbeat, diabetes, a certain eye...

Read All Potential Precautions of Pseudovent 400 Capsules »


Pseudovent 400 Capsules Consumer (continued)

SIDE EFFECTS: Nausea or headache may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, fainting, fast/irregular/pounding heartbeat, mental/mood changes (such as anxiety, confusion, nervousness, irritability), shaking (tremor), trouble sleeping, difficult/painful urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a bad reaction to similar drugs (sympathomimetics such as ephedrine, phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus, high blood pressure, heart disease (such as chest pain, heart failure, heart attack), fast/slow/irregular heartbeat, diabetes, a certain eye problem (glaucoma), difficulty urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this product in children because they may be more sensitive to its side effects, especially nervousness, irritability, and high blood pressure. (See also Uses Section.)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

The pseudoephedrine in this product passes into breast milk and may have undesirable effects on a nursing infant. It is unknown if guaifenesin passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.



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