Brand Names: Altarussin PE, Ambifed, Biotuss PE, Despec-SR, D-Feda II, Dynex, ExeFen, Guiatex II SR, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Robitussin Severe Congestion, Ru-Tuss Jr., Sudafed Non Drying Sinus, SudaTex-G, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

Generic Name: guaifenesin and pseudoephedrine (Pronunciation: gwye FEN e sin, soo doe e FED rin)

• What is guaifenesin and pseudoephedrine (Guaifenex PSE 60)?
• What are the possible side effects of guaifenesin and pseudoephedrine?
• What is the most important information I should know about guaifenesin and pseudoephedrine?
• What should I discuss with my healthcare provider before taking guaifenesin and pseudoephedrine?
• How should I take guaifenesin and pseudoephedrine?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking guaifenesin and pseudoephedrine?
• What other drugs will affect guaifenesin and pseudoephedrine?
• Where can I get more information?

What is guaifenesin and pseudoephedrine (Guaifenex PSE 60)?

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.

Congestac

oblong, white, imprinted with C

Deconsal II

oblong, blue, imprinted with Adams, 017

Guaifenex PSE 60

oblong, blue, imprinted with ETHEX, 214

Guaifenex PSE 800 mg-80 mg

oblong, white, imprinted with 413, ETHEX

Guaifenex PSE 85

oblong, white, imprinted with ETHEX, 478

Respaire 120 mg

clear/orange, imprinted with LASER 0169

Respaire 60 mg

clear/green, imprinted with LASER 0174

What are the possible side effects of guaifenesin and pseudoephedrine?

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.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about 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.