Acetaminophen/Ibuprofen Combo Coming This Year–At Last

As pharmaceutical companies continue their search for non-opioid pain relief, we’ve made solid, evidence-based progress, and one of the most consistent research findings is this: acetaminophen combined with ibuprofen is a spectacular combination for managing post-procedural dental pain.

This combination delivers everything the human system needs for short-term relief of acute, traumatic discomfort: anti-inflammatory action reduces the swelling and pressure that causes aching due to pressure on nerves in sensitive tissues, and analgesic properties contribute additional sensation dulling.

As of March 2,2020, with a fresh FDA approval in hand, GlaxoSmithKline is ready to bring this combination to market in the U.S. in a single-pill formula.

This is exciting news for health consumers.

Fewer Pill Bottles, More Pain Relief

I’ve been talking about the desirability of an acetaminophen/ibuprofen combination for quite some time, both because of its ability to reduce pill load and because we do already have widespread OTC clinical experience with this drug combination already–Australia, to be specific.

The reluctance to swallow a large number and variety of pills can be one of the most significant barriers to non-opioid pain relief. Patients with anxiety about home medication management and pill swallowing welcome simpler, streamlined medication options, and a single-pill solution that reduces both swelling and direct neural pain can reduce pressures on clinicians for opioid prescriptions.

This new formulation, which was evaluated in 7 clinical studies, “supports a pain relief indication and demonstrates that the fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone,” according to the approval announcement by GSK.

The primary issue I can initially foresee as care providers begin to recommend the new combination is the fixed-dose formulation. If more of one property (pain relief or anti-inflammatory action) is needed or recommended after a specific procedure, the clinician may recommend separate preparations rather than a fixed-dose combination. Otherwise, a single-pill delivery system offers efficiency and predictability.

With 125 mg/ibuprofen/250 acetaminophen per tablet, the new product (once it is released for sale) should be limited to the maximum safe dose of each of its constituent ingredients.

Cautions with Acetaminophen and Ibuprofen

The recommended limits for adults and children over 12 are:

3,000 mg per day of acetaminophen

2,400 mg per day of ibuprofen

Safety and efficacy studies, as well as general safe prescribing practices, set the maximum safe dosing for acute inflammatory pain at:

  • Four tablets at one time
  • Three times per day
  • For no more than three days

As with other pain relief formulations containing acetaminophen, avoiding alcohol, cigarette smoke, and other hepatotoxic (dangerous to the liver) substances while taking the new combination will be critical for patient safety.


  1. Good to know – I know I use that combination for my own aches and pains on occasion and have recommended it to my patients. Great idea to have it combined into one tablet!

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