Vicks VapoSyrup Severe Congestion® (as a combination product containing Guaifenesin, Phenylephrine)
Viratan DM® (as a combination product containing Dextromethorphan, Phenylephrine, Pyrilamine)§
Viravan DM® (as a combination product containing Dextromethorphan, Phenylephrine, Pyrilamine)§
Viravan T® (as a combination product containing Phenylephrine, Pyrilamine)§
Visonex® (as a combination product containing Guaifenesin, Phenylephrine)§
Wellbid D® (as a combination product containing Guaifenesin, Phenylephrine)§
Y-Cof DMX® (as a combination product containing Brompheniramine, Dextromethorphan, Phenylephrine)
Z-Dex® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
Zotex® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)§
FDA Intends to RemoveSomeUnapproved Cough, Cold, and Allergy Drugs from the Market
This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
the possibility of improper use in infants and young children
potentially risky combinations of ingredients
patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:
You can visit the FDA website ( Web Site) for more information about this action to remove unapproved cough, cold, and allergy products from the market.
You can find a list of unapproved products by going to ( Web Site).
For information on how to dispose of unused products, go to Web Site.
WHY is this medicine prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
HOW should this medicine be used?
Phenylephrine comes as a tablet, a liquid, or a dissolving strip to take by mouth. It is usually taken every 4 hours as needed. It is also available in extended release forms that are usually taken one or two times a day. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take phenylephrine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.
Phenylephrine comes alone and in combination with other medications. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
Nonprescription cough and cold combination products, including products that contain phenylephrine, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.
If you are giving phenylephrine or a combination product that contains phenylephrine to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give phenylephrine products that are made for adults to children.
Before you give a phenylephrine product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.
If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
If your symptoms do not get better within 7 days or if you have a fever, stop taking phenylephrine and call your doctor.
If you are taking the dissolving strips, place one strip on your tongue and allow it to dissolve.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking phenylephrine,
tell your doctor and pharmacist if you are allergic to phenylephrine or any other medications.
do not take phenylephrine if you are taking a monoamine oxidase (MAO) inhibitor, such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 2 weeks.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
tell your doctor if you have or have ever had high blood pressure, diabetes, trouble urinating because of an enlarged prostate gland, or thyroid or heart disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking phenylephrine, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking phenylephrine.
if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some phenylephrine products may be sweetened with aspartame, a source of phenylalanine.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
This medication is usually taken as needed. If your doctor has told you to take phenylephrine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Phenylephrine may cause side effects. Some side effects can be serious. If you experience any of these symptoms, stop using phenylephrine and call your doctor:
Phenylephrine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Ask your pharmacist any questions you have about phenylephrine.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
§ These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs ( Web Site ) and the approval process ( Web Site ).
¶ This branded product is no longer on the market. Generic alternatives may be available.
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