Zotex-GP

• If you have an allergy to guaifenesin, phenylephrine, or any other part of Zotex-GP (guaifenesin and phenylephrine tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you have a cough with a lot of mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.

This is not a list of all drugs or health problems that interact with Zotex-GP.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your 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.
• Feeling sleepy.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Zotex-GP (guaifenesin and phenylephrine tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zotex-GP. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Zotex-GP.

Review Date: October 4, 2017

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