IBUPROFEN (IBUPROFEN 200MG)

ADVANCED FIRST AID, INC. · tablet, film coated · NDC 67060-001

Listed in the FDA National Drug Code directory

IBUPROFEN is an over-the-counter medicine made available by ADVANCED FIRST AID, INC., on the U.S. market since April 2015. It is marketed under an FDA approval (ANDA ANDA079174), 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 23, 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 IBUPROFEN 200MG IBUPROFEN IBUPROFEN SILICON DIOXIDE POVIDONE K30 FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID POLYETHYLENE GLYCOL 400 HYPROMELLOSE 2208 (4000 MPA.S) STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE LACTOSE MONOHYDRATE TRIACETIN G2

Text on the package panel: ADVANCED IBUPROFEN

What it is for

pain reliever/fever reducer

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 • 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 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 con…

Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.

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Recalls of this product

No FDA recalls are recorded for NDC 67060-001. Recalls are listed in FDA enforcement reports from 2004 onward.

Most reported side effects for ibuprofen 200mgReports to the FDA Adverse Event Reporting System (FAERS), all products with this ingredient
Drug ineffective15,937 reports
Pain15,214 reports
Fatigue14,701 reports
Nausea13,731 reports
Headache12,255 reports
Arthralgia11,065 reports
Dyspnoea10,667 reports
Vomiting10,129 reports
Diarrhoea9,838 reports
Rash9,154 reports
Show as table
ItemValue (reports)
Drug ineffective15,937
Pain15,214
Fatigue14,701
Nausea13,731
Headache12,255
Arthralgia11,065
Dyspnoea10,667
Vomiting10,129
Diarrhoea9,838
Rash9,154

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

Brand
IBUPROFEN
Generic name
IBUPROFEN 200MG
Company
ADVANCED FIRST AID, INC.
Form
tablet, film coated
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2026
Product NDC
67060-001

Active ingredients

Ibuprofen
200 mg/1

Packages (2)

The last part of the NDC identifies the pack size. Your box should show one of these.

67060-001-67 250 packet in 1 carton (67060-001-67) / 2 tablet, film coated in 1 packet
67060-001-68 100 packet in 1 carton (67060-001-68) / 2 tablet, film coated in 1 packet

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.