Mardrops-EX

• It is used to treat nose stuffiness.
• It is used to thin mucus so it can be taken from the body by coughing.

• Tell all of your health care providers that you take Mardrops-EX. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Mardrops-EX affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Different brands of Mardrops-EX may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Mardrops-EX while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Measure liquid doses carefully. Use the measuring device that comes with Mardrops-EX. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

• If you take Mardrops-EX (guaifenesin and pseudoephedrine liquid) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to guaifenesin / pseudoephedrine: oral capsule, oral capsule extended release, oral liquid, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included significant increases in heart rate. Hypertension and arrhythmias have also been problematic in susceptible patients.[Ref]

Pseudoephedrine may cause vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also been reported in patients receiving pseudoephedrine. Guaifenesin has occasionally caused dizziness and headache.[Ref]

Gastrointestinal

Gastrointestinal side effects associated with pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients. Gastrointestinal upset and vomiting have been reported with higher than recommended doses of guaifenesin. Doses recommended for expectoration have rarely been associated with gastrointestinal upset.[Ref]

Hypersensitivity

Hypersensitivity side effects have included fixed drug eruptions secondary to pseudoephedrine.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of rash.[Ref]

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