Vanacon

Do not use this medicine within 14 days before or 14 days after you have used an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you are allergic to guaifenesin, hydrocodone, or pseudoephedrine, or if you have:

• narrow-angle glaucoma;

• severe or uncontrolled high blood pressure;

• coronary artery disease (clogged arteries); or

• if you are unable to urinate.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• asthma or other breathing problems;

• a head injury or increased pressure inside your skull;

• diabetes;

• thyroid disorder;

• Addison's disease (an adrenal gland disorder);

• alcoholism or drug addiction;

• enlarged prostate or urination problems;

• liver or kidney disease;

• stomach problems; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use hydrocodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Hydrocodone and pseudoephedrine can pass into breast milk, but effects on the nursing baby are not known. Decongestants can also slow beast milk production. You should not breast-feed while taking this medicine.

Guaifenesin, hydrocodone, and pseudoephedrine is not approved for use by anyone younger than 18 years old.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme weakness, cold and clammy skin, breathing problems, pounding heartbeats, confusion, hallucinations, slurred speech, blue lips, severe drowsiness, slow breathing, fainting, or breathing that stops.

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

Like other opioid medicines, hydrocodone can slow your breathing. Death may occur if breathing becomes too weak.

Stop using this medicine and call your doctor at once if you have:

• severe weakness, severe drowsiness, confusion;

• weak or shallow breathing;

• tremors, severe restlessness;

• severe constipation, stomach pain;

• low blood pressure (feeling light-headed, or like you might pass out);

• a seizure;

• painful or difficult urination; or

• irregular heartbeats.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects may include:

• dizziness, drowsiness;

• headache;

• sleep problems (insomnia);

• nausea; or

• low blood pressure.

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.

Applies to guaifenesin / hydrocodone / pseudoephedrine: oral elixir, oral liquid, oral solution, oral syrup, oral tablet

Along with its needed effects, guaifenesin / hydrocodone / pseudoephedrine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking guaifenesin / hydrocodone / pseudoephedrine:

• Abdominal or stomach cramps or pain
• bloating
• blurred vision
• chest pain or discomfort
• cold, clammy, pale skin
• confusion
• constipation
• convulsions
• diarrhea
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• sweating
• trembling or shaking of the hands or feet
• unusual tiredness or weakness
• vomiting

Some side effects of guaifenesin / hydrocodone / pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• drowsiness
• feeling of warmth
• headache
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm
• sleepiness
• sudden sweating

• Trouble sleeping

Applies to guaifenesin / hydrocodone / pseudoephedrine: oral liquid, oral tablet

General

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