Motrin PM (Ibuprofen and Diphenhydramine Citrate)
Kenvue Brands LLC · tablet, coated · NDC 50580-563
Motrin PM is an over-the-counter medicine made available by Kenvue Brands LLC, on the U.S. market since January 2010. It is marketed under an FDA approval (ANDA ANDA079113), so the FDA has reviewed its safety, effectiveness and manufacturing. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
What the genuine product looks like
From the official FDA label (version of Jul 11, 2025). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.
Product data on the label: Motrin PM Ibuprofen and Diphenhydramine Citrate SILICON DIOXIDE CROSCARMELLOSE SODIUM GLYCERYL BEHENATE/EICOSADIOATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE MOTRIN;PM
Text on the package panel: PRINCIPAL DISPLAY PANEL See Revised Warning NDC 50580-563-80 Motrin ® PM Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg Tablets Pain Reliever (NSAID)/Nighttime Sleep-Aid 80 Coated Caplets** **Capsule-Shaped Tablets Actual Size CAPLETS** motrin-01
What it is for
Active ingredients (in each caplet) Purposes Diphenhydramine citrate 38 mg Nighttime sleep-aid Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever
Key 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 [a…
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
Recalls of this product
No FDA recalls are recorded for NDC 50580-563. Recalls are listed in FDA enforcement reports from 2004 onward.
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 2,823 |
| Pain | 1,964 |
| Nausea | 1,806 |
| Headache | 1,740 |
| Fatigue | 1,423 |
| Dizziness | 1,227 |
| Vomiting | 1,092 |
| Anxiety | 1,072 |
| Drug hypersensitivity | 1,047 |
| Diarrhoea | 939 |
These counts are reports, not proof that the medicine caused the problem. Popular medicines get more reports simply because more people take them. They are useful for spotting what to watch for, not for comparing medicines.
Official listing
Active ingredients
Packages (2)
The last part of the NDC identifies the pack size. Your box should show one of these.
Think your pack is fake?
Stop taking it, keep the pack and receipt, and show it to a pharmacist. In the U.S., report it to FDA MedWatch; elsewhere, to your national medicines regulator. How to spot a fake medicine.
Source: openFDA (U.S. Food and Drug Administration) drug directory, labels, enforcement reports and FAERS, retrieved Nov 8, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.