CGMP Deviations
CAREONE DUAL ACTION (Acetaminophen, Ibuprofen)
Retail Business Services, LLC · tablet, film coated · NDC 72476-231
Listed in the FDA National Drug Code directory
CAREONE DUAL ACTION is an over-the-counter medicine made available by Retail Business Services, LLC, on the U.S. market since August 2025. It is marketed under an FDA approval (ANDA ANDA214836), 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 Aug 25, 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: CAREONE DUAL ACTION Acetaminophen, Ibuprofen ACETAMINOPHEN ACETAMINOPHEN IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FERRIC OXIDE YELLOW MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE II
Text on the package panel: Package/Label Principal Display Panel CAREone ® Compare to the active ingredients in Advil® Dual Action DUAL ACTION Acetaminophen 250 mg & Ibuprofen (NSAID) 125 mg Tablets Pain Reliever Actual Size CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen Gluten Free 72 CAPLETS** **Capsule-Shaped Tablets careone-dual-action-carton-image.jpg
What it is for
Purposes Pain reliever
Key warnings
Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 caplets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people all…
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 72476-231. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of acetaminophen, ibuprofen
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Drug ineffective60 reports
Drug effective for unapproved indication30 reports
Therapeutic product effect incomplete29 reports
Off label use16 reports
Drug effect less than expected15 reports
Diarrhoea14 reports
Fatigue13 reports
Malaise13 reports
Underdose13 reports
Constipation12 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 60 |
| Drug effective for unapproved indication | 30 |
| Therapeutic product effect incomplete | 29 |
| Off label use | 16 |
| Drug effect less than expected | 15 |
| Diarrhoea | 14 |
| Fatigue | 13 |
| Malaise | 13 |
| Underdose | 13 |
| Constipation | 12 |
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
CAREONE DUAL ACTION
Generic name
Acetaminophen, Ibuprofen
Company
Retail Business Services, LLC
Form
tablet, film coated
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
72476-231
Active ingredients
Acetaminophen
250 mg/1
Ibuprofen
125 mg/1
Packages (2)
The last part of the NDC identifies the pack size. Your box should show one of these.
72476-231-23 1 bottle in 1 carton (72476-231-23) / 72 tablet, film coated in 1 bottle
72476-231-89 1 bottle in 1 carton (72476-231-89) / 18 tablet, film coated in 1 bottle
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.