Bayer Healthcare LLC recently issued the following announcement.
Approval Date: 04/10/2019
Drug Name: ALEVE PM NDA #205352
Submission: SUPPL-13
Active Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Company: BAYER HLTHCARE
Submission Classification *: Labeling
Submission Status: Approval
What is Aleve PM?
Aleve PM is the first and only over-the-counter (OTC) PM product with the 12-hour pain-relieving strength of Aleve plus a sleep aid. Each caplet combines the sleep aid diphenhydramine HCl (25 mg) with the pain reliever naproxen sodium (220 mg), a nonsteroidal anti-inflammatory drug, to provide relief from occasional sleeplessness associated with minor aches and pains. It can help you fall asleep and stay asleep.
What are the active ingredients in Aleve PM?
Each caplet contains 220 mg of naproxen sodium, an NSAID pain reliever and 25 mg of diphenhydramine HCl, which is a sleep aid.
What is Aleve PM used for?
Aleve PM is used for relief of occasional sleeplessness associated with minor aches and pains and to help you fall asleep and stay asleep
How does Aleve PM work?
Aleve PM can help you fall asleep and stay asleep with less pain for a good night's rest. The naproxen sodium (220 mg) in Aleve PM works by temporarily blocking the body's production of naturally occurring chemicals called prostaglandins. Prostaglandins play a direct role in pain. The diphenhydramine HCl in Aleve PM acts as a sleep aid. Adults and children 12 years and over should take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours. Not for children under 12 years of age. Please read the label and use as directed.
How is Aleve PM different from regular Aleve?
Aleve PM is for occasional sleeplessness due to minor pain. It contains the same pain reliever found in Aleve (naproxen sodium) but also has a sleep aid (diphenhydramine HCl), so you can fall asleep and stay asleep and have a good night's rest.
Is Aleve PM an anti-inflammatory?
Each Aleve PM caplet combines the pain reliever naproxen sodium (220 mg), part of a class of medication known as nonsteroidal anti-inflammatory drugs (NSAIDs), but is not indicated as an anti-inflamatory. Aleve PM also contains the sleep aid diphenhydramine HCl (25 mg). You should consult your doctor if you have questions about whether Aleve PM is right for you.
Is Aleve PM a sleep aid?
Each Aleve PM caplet combines the sleep aid diphenhydramine HCl (25 mg) with the pain reliever naproxen sodium (220 mg) to provide relief from occasional sleeplessness associated with minor aches and pains. And if pain is keeping you up at night, it can help you fall asleep and stay asleep.
Will Aleve PM treat allergy symptoms?
No, Aleve PM is not indicated to treat allergy symptoms. Although Aleve PM contains diphenhydramine HCl, which can be used as both an antihistamine and a sleep aid, it is indicated as a sleep aid in this product. Aleve PM should be used according to the labeled directions.
What are the benefits of Aleve PM?
Aleve PM can provide relief from occasional sleeplessness associated with minor aches and pain. Aleve PM is the first and only over-the-counter (OTC) PM product with the 12-hour pain-relieving strength of Aleve plus a sleep aid.
Has Aleve PM been found to be safe?
Yes, Aleve PM was found to be safe in clinical trials. Aleve PM is indicated for occasional sleeplessness associated with minor aches and pain. Aleve PM is safe and effective when used as directed.
What is the safety history of the ingredients in Aleve PM?
The two active ingredients in Aleve PM, naproxen sodium and diphenhydramine HCl, have a long history of being safe and effective when used as directed. Naproxen sodium has been used for over 30 years; diphenhydramine HCl has been used for over 60 years.
Is Aleve PM as safe as Aleve?
Both products were approved by the FDA as safe and efficacious when used according to labeled directions.
What are the possible side effects of Aleve PM?
In clinical studies, the most common side effects were nausea, headaches, dizziness and vomiting. Refer to the Aleve PM drug facts label and use as directed.
As with all NSAIDs, this product contains a stomach bleeding warning and may cause severe stomach bleeding.
As with all NSAIDS, this product contains an allergy warning. Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin and other NSAIDs. If an allergic reaction occurs, stop use and seek medical help right away.
If you have experienced any side effect, stop use and consult with your doctor. See package labeling for complete information and warnings
Can/should Aleve PM be taken with food?
If stomach upset occurs, Aleve PM can be taken with food or milk. If taken with food, the product may take longer to work.
Can you take Aleve with Aleve PM?
Aleve PM should not be taken at the same time as Aleve in a 24-hour period, as it contains the same pain reliever as Aleve, naproxen sodium. Be sure to read all labels before use.
Can you take Aleve PM during the day?
Aleve PM is indicated to be taken at bedtime for occasional sleeplessness due to minor pain.
What if you take more Aleve PM caplets than directed within a 24-hour period?
It is not recommended to take more than 2 caplets within 24 hours. Please refer to the Aleve PM drug facts label and use as directed
Is Aleve PM habit-forming?
The FDA has approved Aleve PM as safe and effective when used as directed. Aleve PM contains a non-habit-forming sleep aid, diphenhydramine HCl, and a pain reliever, naproxen sodium.
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