Haleon US Holdings LLC · tablet, coated · NDC 0573-0164
ADVIL PM is an over-the-counter medicine made available by Haleon US Holdings LLC, on the U.S. market since December 2005. It is marketed under an FDA approval (NDA NDA021394), 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.
From the official FDA label (version of Apr 8, 2024). 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: ADVIL PM diphenhydramine citrate and ibuprofen CALCIUM STEARATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN blue Advil;PM
Text on the package panel: Principal Display Panel NDC 0573-0164-20 Advil PM Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg Pain Reliever (NSAID) / Nighttime Sleep-Aid 20 Coated Caplets* *Capsule-Shaped Tablets Advil PM 20 Coated Caplets
Purposes Nighttime sleep-aid Pain reliever
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 …
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
| Item | Value (reports) |
|---|---|
| Drug ineffective | 1,177 |
| Somnolence | 424 |
| Product use in unapproved indication | 346 |
| Drug effective for unapproved indication | 283 |
| Insomnia | 244 |
| Feeling abnormal | 223 |
| Fatigue | 189 |
| Dizziness | 179 |
| Intentional product misuse | 145 |
| Headache | 119 |
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.
The last part of the NDC identifies the pack size. Your box should show one of these.
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.