Awake Oral Warnings
Awake Oral Uses
This medication should not be used to replace sleep.
This medication should not be used in children younger than 12 years old.How to use Awake Oral
Take this product by mouth as directed. Follow all directions on the product package, or take as directed by your doctor. If you are uncertain about any of the information, consult your doctor or pharmacist.
This medication should only be used as needed, not on a regular basis. Though very unlikely, this medication may be habit-forming. Do not increase your dose, take it more frequently than directed, or take it regularly for a long time.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as headaches, mental/mood changes such as irritation/nervousness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
When used for an extended period, this medication may not work as well. Talk with your doctor if this medication stops working well.
Tell your doctor if your condition persists, worsens, or continues to occur again. If you think you may have a serious medical problem, seek immediate medical attention.
Awake Oral Side Effects
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Awake Oral Precautions
Before taking caffeine, tell your doctor or pharmacist if you are allergic to it; or to other xanthine drugs (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heart rhythm, recent heart attack), high blood pressure, stomach/intestinal ulcers, mental/mood disorders (e.g., anxiety, nervousness).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Awake Oral Interactions
If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adenosine, certain asthma medications (theophylline, beta-agonists such as albuterol), ciprofloxacin, disulfiram, drugs affecting liver enzymes that remove caffeine from your body (such as cimetidine, fluvoxamine), lithium.
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, headache medications) because they may contain caffeine or ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.
Avoid drinking large amounts of beverages containing caffeine (coffee, tea, certain sodas) or eating large amounts of chocolate while taking this medication.
This medication may interfere with certain medical/laboratory tests (including urine VMA/catecholamines levels, dipyridamole-thallium imaging test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Awake Oral Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: stomach/abdominal pain, mental/mood changes, seizures, fast/irregular heartbeat.NOTES:
Keep all regular medical and laboratory appointments.MISSED DOSE:
Refer to storage information printed on the package. Protect from light and moisture. Do not store in the bathroom. If you have any questions about storage, ask your pharmacist. Keep all drug products away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.