Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine
Consumers have many choices for treating symptoms of cold, allergies and nasal congestion
FDA’s Actions on OTC Oral Phenylephrine
FDA regulates over-the-counter (OTC), also known as nonprescription, drugs to ensure that they are safe and effective for consumers. It is important that consumers have access to safe and effective drugs.
FDA is proposing to remove oral phenylephrine as an active ingredient from certain common medications that temporarily relieve symptoms of nasal congestion from the common cold or allergies.
Drug products that contain oral phenylephrine can still be marketed until the agency issues a final order. This is the first step in the process FDA would take to finalize its determination that oral phenylephrine is not effective and, at this time, oral phenylephrine can continue to be an ingredient in drug products. The public can comment on this proposal, and FDA will review the public comments before finalizing a decision.
There is a wide range of safe and effective drugs that are available for the temporary relief of nasal congestion symptoms due to allergies or a common cold. Talk to your doctor or pharmacist about your options.
Key Information About Cough and Cold Nonprescription (OTC) Drugs
- Always read the Drug Facts label (DFL) of your nonprescription drug.
The DFL is usually on the back of a package, and it contains important information about how to use the drug, the dosage, its risks, and other important information. - Talk to your doctor or pharmacist about your options.
There are many options to treat the symptoms of the common cold and allergies. Your doctor or pharmacist can help you choose the best nonprescription drug or advise you when you have symptoms. - Be aware of all the ingredients in your nonprescription drugs.
Many cough, cold, and nasal decongestion products will contain more than one active ingredient. It is important to be aware of taking more than one drug at a time, so that you do not take an extra dose of the ingredients. For example, acetaminophen is in many common brands of nonprescription drugs. Taking more than the maximum daily dose of acetaminophen can lead to liver failure. - Understand there are different concerns for children and people who are pregnant.
If you are pregnant or give medicine to children, always read the label fully or talk to your doctor or pharmacist about your options. Many cough and cold products contain warnings for young children or for people who are pregnant. - Visit MedWatch for additional safety information about drugs, or to report adverse events.
If you need information or if you have questions or comments about a medical product, please call FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.
Questions and Answers about Phenylephrine
Oral phenylephrine, also known as oral PE, is a common ingredient used in OTC drug products to temporarily relieve symptoms of nasal congestion from the common cold or allergies.
Check the Drug Facts label for active ingredients. All active ingredients will be listed there.
Yes. If your drug product has oral phenylephrine you may continue to use it. Some OTC drug products contain other active ingredients (e.g., acetaminophen) in addition to phenylephrine that treat symptoms of colds or allergies, like headaches or muscle aches. The presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms.
There are a number of OTC drugs that can be used to treat nasal congestion symptoms related to colds or allergies. Other OTC drugs that can be used to treat nasal congestion include oral pseudoephedrine and nasal sprays with nasal decongestants, nasal corticosteroids and nasal antihistamines. Consumers should review the Drug Facts label to determine what is best for them. Regardless of the drug you choose, it is important to read the label every time you use one of these products and to use as directed.
There are also other options to treat nasal congestion symptoms, especially for children. This can include cool mist humidifiers, saline nose drops or sprays, and nasal suctioning with a bulb syringe.
You can ask your doctor or pharmacist for advice about what to use for your symptoms. It is important to seek the help of a healthcare professional if symptoms of nasal congestion do not improve within 7 days or are accompanied by fever.
- Should You Give Kids Medicine for Coughs and Colds?
- Seasonal Allergies: Which Medicine is Right for You?
- Don't Double Up on Acetaminophen
Drug products that contain oral phenylephrine can continue to be marketed at this time. Pharmacies may choose to remove some products which contain oral phenylephrine as an active ingredient from store shelves even though FDA is not requesting pharmacies do this.
Talk to your doctor or pharmacist about your options.
Issuing a proposed order is just one of several steps that FDA is required to complete before it finalizes its decision. The public will be able to comment on this proposed order. If after considering the public’s comments, FDA concludes oral phenylephrine is not effective as a nasal decongestant, the agency will issue a final order removing oral phenylephrine from its associated OTC monograph and nasal decongestant drug products marketed under the OTC monograph would no longer be allowed to contain oral phenylephrine. FDA will let the public know when it takes any future actions.
No, FDA’s action only applies to phenylephrine-containing products that are taken orally.
FDA evaluated to see whether there is a potential safety issue (safety signal) for oral phenylephrine. Even though oral phenylephrine is widely used, FDA identified very few cases of serious side effects when oral phenylephrine is taken by consumers as directed in the label of the drug product.
Additional Information
- FDA News Release: FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review
- FDA clarifies results of recent advisory committee meeting on oral phenylephrine
- The Over-the-Counter Drug Facts Label
- Listen to the Q&A with FDA Podcast, The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein
- Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine
- MedWatch
- UPDATED: September 11-12, 2023: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement - 09/11/2023
- OTC Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use