You've got the sniffles and your nose is running like a tap. The tissues feel like sandpaper.
Many Australians reach for cold and flu tablets, expecting them to "clear the sinuses" and get them through a cold. They often promise fast relief.
But the evidence is clear: for nasal congestion, these medicines do not work as well as they claim. So why are they still being sold?
What's actually in cold and flu tablets?
Most over-the-counter cold and flu tablets contain a mix of ingredients. Some packs contain different tablets for day and night.
"Day" products often include paracetamol or ibuprofen to ease aches and pains, along with a decongestant for a runny or blocked nose. "Night" products typically have an extra ingredient - an antihistamine to make you drowsy and help with sleep.
In Australia, the most common oral decongestant used in these products is phenylephrine. It works by narrowing blood vessels in the nose, reducing swelling and making it easier to breathe.
You can also buy phenylephrine as a nose spray, although it's less common. If you spray phenylephrine into your nose it works well as a decongestant. But a large body of research has established it has almost no effect when swallowed in a tablet.
So, why is phenylephrine still widely sold?
Some important context
In the early 2000s, the main decongestant in cold and flu tablets was pseudoephedrine. Phenylephrine was rare as an oral medicine, though it had been available as a nose spray since the 1990s.
But between 1996 and 2005 there was a significant spike in illicit drug manufacture in Australia.
Pseudoephedrine - available over the counter - was one of the chemicals being used to make amphetamines including "ice" and "speed". So pharmacies were increasingly targeted in break-ins, ram raids and armed hold-ups .
This led to tightened restrictions on the sale of pseudoephedrine products, including their reclassification in 2006 as "pharmacist only". This meant they could be bought without a prescription, but "behind the counter" - a pharmacist had to be involved in the sale.
Pseudoephedrine became much harder to obtain, whether the intention was to use it legitimately, or not.
Phenylephrine replaced pseudoephedrine as the main decongestant in oral products, not because it was a better medicine but because there was less risk of it being misused.
Early studies and reviews suggested phenylephrine was an effective alternative.
But the evidence has changed
Over time, better research has begun to tell a different story, particularly about phenylephrine taken orally.
Recent studies have shown oral phenylephrine performs no better than a placebo for relieving nasal congestion.
Overall evidence on oral phenylephrine is now consistent : it does not meaningfully relieve nasal congestion when taken by mouth.
This is because, when take orally, only a very small amount of phenylephrine can get into the bloodstream and reach the nose .
In contrast, a nasal spray delivers the drug directly to the nasal passages, where it can act on the blood vessels.
Why are these medicines still on shelves?
In 2023, an independent advisory committee to the US Food and Drug Administration (FDA) reviewed the evidence and concluded oral phenylephrine is not effective for nasal congestion when given at standard doses.
In November 2024, the FDA proposed removing oral phenylephrine from over-the-counter cold and flu tablets .
In Australia, the Therapeutic Goods Administration (TGA) is responsible for regulating these medicines.
A spokesperson for the TGA told The Conversation the regulator is aware of the FDA's proposal to remove oral phenylephrine from over-the-counter sale, "based on efficacy concerns not safety concerns".
The spokesperson said: "At this time, while the TGA does not have current plans to conduct a review of the effectiveness of oral phenylephrine, we will continue to monitor the outcomes of the FDA review and consultation."
The FDA has not yet announced the outcome of the proposal.
So, are cold and flu tablets safe?
While the evidence supporting oral phenylephrine as an effective decongestant has changed, the main concern is not that it causes harm. It's that consumers will pay more for a medicine that provides little relief for nasal congestion.
If people do feel better after taking cold and flu tablets, it's likely because of other ingredients, such as ibuprofen or paracetamol.
In Australia, products containing phenylephrine must be clearly labelled, allowing consumers to make an informed choice .
What actually helps when you have a cold or flu?
For nasal congestion, short-term use of a decongestant nasal spray containing phenylephrine, oxymetazoline or xylometazoline can provide relief . This means using them for a maximum of three days.
Using them for longer can cause your symptoms to worsen or come back worse when you stop using it - this is called rebound congestion.
Saline nasal sprays or rinses also help to clear nasal congestion safely and effectively , by physically dislodging phlegm, without the risk of rebound congestion.
For other options, speak to your pharmacist. In some cases, a GP or pharmacist may recommend products that contain pseudoephedrine. You may need to show identification to the pharmacist, depending on the state or territory.
Paracetamol and ibuprofen can also help ease symptoms such as headache, body aches and fevers. Steam inhalation or warm showers may provide some temporary relief.__
But there is no way to treat the cause, which is typically a virus.
The best thing you can do is rest, stay hydrated, and keep your germs to yourself. You should start feeling better in around seven to ten days and, if not, it's time to see your doctor.
Jack Janetzki works for Adelaide University, Pharmaceutical Defence Limited and The Barossa Pharmacist in the Mall (Nuriootpa, South Australia). He is an ethics committee member for Bellberry, a member of Pharmaceutical Defence Limited, the Australasian Pharmaceutical Science Association, the Pharmaceutical Society of Australia and the Observational Health Data Science and Informatics (OHDSI) network.
Lauren Cortis does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
