Rynex DM

• Edwards Pharmaceuticals, Inc.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• fast, slow, or uneven heart rate;

• severe headache, mood changes, hallucinations;

• severe dizziness or anxiety, feeling like you might pass out;

• tremor, seizure (convulsions);

• easy bruising or bleeding, unusual weakness;

• fever;

• urinating less than usual or not at all;

• feeling short of breath; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

• mild headache;

• mild dizziness, drowsiness;

• dry mouth, nose, or throat;

• nausea, diarrhea, constipation, upset stomach;

• feeling nervous, restless, or irritable;

• blurred vision; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Rynex DM 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.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Rynex DM.

What do I do if I miss a dose?

• If you take this medicine 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 Rynex DM (brompheniramine, dextromethorphan, and phenylephrine) 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.

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.

• 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.

Applies to brompheniramine / dextromethorphan / phenylephrine: oral elixir, oral liquid, oral syrup

Applies to brompheniramine / dextromethorphan / phenylephrine: oral liquid, oral suspension extended release

Cardiovascular

Cardiovascular side effects have included hypotension, hypertension, cardiac arrhythmias, palpitations, tachycardia and pallor.[Ref]

Dermatologic

Dermatologic side effects have included urticaria, drug rash, photosensitivity, and pruritus.[Ref]

Nervous system

Nervous system side effects have included disturbed coordination, tremor, irritability, insomnia, weakness, nervousness, convulsions, headache, euphoria, dysphoria, restlessness, hallucinations, and central nervous system depression.[Ref]

Ocular

Ocular side effects have included visual disturbances.[Ref]

Respiratory

Respiratory side effects have included thickening of bronchial secretions, respiratory difficulty, shortness of breath, tightness of chest and wheezing.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dryness of mouth, nose and throat, epigastric discomfort, nausea, vomiting, diarrhea, and constipation.[Ref]

Genitourinary

Genitourinary side effects have included urinary frequency and difficult urination.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, thrombocytopenia, and agranulocytosis.[Ref]

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