Leader Ibuprofen PM (diphenhydramine citrate, ibuprofen)
Cardinal Health 110, LLC. dba Leader · tablet, film coated · NDC 70000-0157
Leader Ibuprofen PM is an over-the-counter medicine made available by Cardinal Health 110, LLC. dba Leader, on the U.S. market since November 2016. 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 Nov 21, 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: Leader Ibuprofen PM diphenhydramine citrate, ibuprofen DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 GLYCERYL DIBEHENATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE L050
Text on the package panel: Principal Display Panel LEADER ™ Ibuprofen PM Ibuprofen, 200 mg | Diphenhydramine Citrate, 38 mg Pain Reliever (NSAID) | Nighttime Sleep-Aid COMPARE TO ADVIL ® PM active ingredients 20 COATED CAPLETS** **Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2
What it is for
Purposes Nighttime sleep-aid 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 n…
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 70000-0157. Recalls are listed in FDA enforcement reports from 2004 onward.
Show as table
| Item | Value (reports) |
|---|---|
| Fatigue | 8 |
| Nausea | 8 |
| Completed suicide | 5 |
| Abdominal distension | 4 |
| Diarrhoea | 4 |
| Hypoaesthesia | 4 |
| Insomnia | 4 |
| Joint swelling | 4 |
| Product use in unapproved indication | 4 |
| Vomiting | 4 |
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.