Paracetamol/naproxen

Paracetamol/naproxen
Combination of
ParacetamolAnalgesic, antipyretic
NaproxenNonsteroidal anti-inflammatory
Clinical data
Trade namesTylenol with Naproxen
AHFS/Drugs.comMicromedex Detailed Consumer Information
Routes of
administration		By mouth
ATC code
Legal status
Legal status

Paracetamol/naproxen, sold under the brand name Tylenol with Naproxen, is a fixed-dose combination of two medications, paracetamol (acetaminophen), an analgesic and antipyretic; and naproxen, as the sodium salt, a non-steroidal anti-inflammatory. It is available over-the-counter.[2] The combination is manufactured by Kenvue Brands.[1]

The combination was approved for medical use in the United States in July 2026.[1]

Medical uses

Paracetamol/naproxen is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis in people aged twelve years of age and older.[1]

Adverse effects

The labeling for the combination includes pregnancy-related recommendations consistent with all other acetaminophen- or NSAID-containing nonprescription products.[1] Specifically, the label advises that those who are pregnant or breast-feeding ask a health professional before use.[1] Also, the label indicates it is important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor.[1]

Social and culture

The combination was approved for medical use in the United States in July 2026.[2]

Names

Paracetamol/naproxen is sold under the brand name Tylenol with Naproxen.[2]

References

  1. 1 2 3 4 5 6 7 "FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief". U.S. Food and Drug Administration (FDA). 24 July 2026. Retrieved 26 July 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  2. 1 2 3 "FDA Approves Tylenol with Naproxen, the First and Only Over-the-Counter Fixed-Dose Combination of Acetaminophen (650 mg) and Naproxen Sodium (220 mg)". Kenvue. 24 July 2026. Retrieved 25 July 2026 – via PR Newswire.
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