ADVIL PM 38 mg/1
diphenhydramine citrate and ibuprofen · TABLET, COATED · Haleon US Holdings LLC
Advil PM is an over-the-counter pain reliever and sleep aid that combines ibuprofen with diphenhydramine, helping to reduce minor aches and pains while promoting sleep. It is taken by mouth as a coated tablet and is intended for temporary relief of minor pain associated with sleeplessness.
Key Facts
- Brand Name
- ADVIL PM
- Generic Name
- diphenhydramine citrate and ibuprofen
- NDC Code (Product)
0573-0164- Manufacturer
- Haleon US Holdings LLC
- Strength
- 38 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021394
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 12/21/2005
Recall History
Pfizer Us Pharmaceutical Group
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Dosage & Administration
Directions • do not take more than directed • adults and children 12 years and over: take 2 capsules at bedtime • do not take more than 2 capsules in 24 hours
Warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night's sleep • in children under 12 years of age • right before or after …
Frequently Asked Questions
What is ADVIL PM used for?
Advil PM is an over-the-counter pain reliever and sleep aid that combines ibuprofen with diphenhydramine, helping to reduce minor aches and pains while promoting sleep. It is taken by mouth as a coated tablet and is intended for temporary relief of minor pain associated with sleeplessness.
Is ADVIL PM a controlled substance?
ADVIL PM is not classified as a controlled substance by the DEA.
What is the generic name for ADVIL PM?
The generic name for ADVIL PM is diphenhydramine citrate and ibuprofen. There are 5 other brand versions of diphenhydramine citrate and ibuprofen.
What is the NDC code for ADVIL PM 38 mg/1?
The NDC (National Drug Code) for ADVIL PM 38 mg/1 is 0573-0164, listed by Haleon US Holdings LLC.