Ibuprofen 200mg (Ibuprofen 200mg)
Allegiant Health · tablet, film coated · NDC 69168-390
Ibuprofen 200mg is an over-the-counter medicine made available by Allegiant Health, on the U.S. market since December 2014. It is marketed under an FDA approval (ANDA ANDA077349), 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 Dec 31, 2018). 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: Ibuprofen 200mg Ibuprofen 200mg IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE STARCH, CORN FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL 1000 SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE
Text on the package panel: Principal Display Panel Ibuprofen 200mg Orange Ibuprofen 200mg Orange
What it is for
Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
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 a nonsteroidal anti-inflammatory drug (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 pr…
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 69168-390. Recalls are listed in FDA enforcement reports from 2004 onward.
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 15,937 |
| Pain | 15,214 |
| Fatigue | 14,701 |
| Nausea | 13,731 |
| Headache | 12,255 |
| Arthralgia | 11,065 |
| Dyspnoea | 10,667 |
| Vomiting | 10,129 |
| Diarrhoea | 9,838 |
| Rash | 9,154 |
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 (1)
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 10, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.