February 12, 2007

Conflicting drug information from "authoritative" sources…

If you do a Google search for "Tylenol #3", the second hit on the page is this link. Looking closely at the page, you'll note that we're talking about "Tylenol #3" specifically. Why then, is the Common Name listed as "acetaminophen – codeine – caffeine"?

There is no caffeine in Tylenol #3. There's just acetaminophen and codeine.

What form(s) does this medication come in?

Tylenol NO. 3 with Codeine®: Each round, hard, white, flat-faced tablet, bevelled-edged, engraved with "3" on one side and "McNEIL" on the other, contains acetaminophen 300 mg and caffeine 15 mg, in combination with codeine phosphate 30 mg. Nonmedicinal ingredients: cellulose, cornstarch, and magnesium stearate. This medication does not contain gluten, lactose, sodium metabisulfite, or tartrazine.

Who should NOT take this medication?

Anyone allergic to acetaminophen, caffeine, or codeine should not take this medication.

In the United States, when a doctor writes "T3" or "Tylenol #3" you're getting 300mg of acetaminophen and 30mg of codeine. No caffeine.

However if you go to the Janssen-Ortho website and hit up their product information PDF for their Tylenol products, it indicates there's caffeine in T2 and T3, but not T4. But the Ortho-McNeil website's prescribing information (PDF), for T3 indicates that it's 300mg APAP and 30mg of codeine. No caffeine.

So WTF is going on here? I called Ortho-McNeil (US makers of T3) and I also called Janssen-Ortho (Canadian counterpart). The US office told me what their website did: no caffeine. I have yet to hear back from the Canadians — they say they'll return your call in one business day. I'm wondering if there's a difference between Canadian T3s and US T3s? Maybe in Canada, they have 15mg of caffeine, whereas in the US, they don't? If this is indeed the case, talk about a nightmare trying to track down accurate consumer information. Yikes.

Update: I just got off the phone with Janssen-Ortho of Canada, and Tylenol #3 in Canada has caffeine in it, which means that it is different than the US formulation of Tylenol #3. If I had trouble figuring this out, how much moreso would your average consumer struggle?

[tags]Medicine, pharmacy, drug information, T3, Tylenol #3[/tags]

View Comments | 10:29 am |

Tracey

Tony, you are talking about Tylenol #1 that is sold over the counter and has 8 mg of codeine plus the other two. Yes, there is a law that there be two non-narcotic ingredients.
T3 is NOT sold OTC, only by prescription same as in the States.
Having a T3 without caffeine is news to me. l had to switch to plain codeine years ago because the caffeine really adds up when you require 8-10 pills during a migraine. But, if you only need a few for a headache - the caffeine helps to shrink the blood vessels that are enlarged in the head causing pain. That's why caffeine has been in headache remedies for so many years. -Going back to Excedrin and Alka Seltzer.
l am wondering --- does the EMTEC 30 pill have caffeine?
Tony

By over the counter, I mean that you actually have to go to the counter and fill out a record with your information. I don't think they actually carry the name tylonol 3 because they have less codeine in them. 300 mg of acetaminophen, 8 mg of codeine and 15 mg of caffeine. Here is an excerpt from wiki, I know it's not always a reliable source, but it really does tell the law:

In Canada, codeine can be sold over the counter only in combination with two or more ingredients, which has resulted in the prevalence of AC&C (aspirin, codeine, and caffeine), and similar combinations using acetaminophen (paracetamol) rather than aspirin. Caffeine, being a stimulant, tends to offset the sedative effects of codeine. It also can increase the effectiveness and absorption rate of analgesics in some circumstances
mike

T-3's or any codein products are prescription only in Canada. You cant get them in the isle.
Tony

Ok, guys, the reason there is caffeine in the Canadian version is because it is sold over the counter there. Whereas in the US it is Rx only. The Caffeine in the Canadian version is put in there to 1) fulfill the law that in order for codeine to be OTC it must contain 2 non narcotic ingredients and 2) Take away some of the sedating effects in hopes to cut down on abuse potential.
Dave Michaels

Note that a cup of coffee has 75 to 100 mg of caffeine. So taking two Tylenol 3s, each with 15 mg of caffeine, is like drinking 2.5 ounces of regular-strength coffee. *That's* why there is still a difference between the US and Canada: because it isn't significant for the vast majority of patients.
Jessa

This is a very interesting topic. In all Tylenol #3 there is caffeine but when you take a prescription to a pharmacy and the doctor has prescribed you Tylenol #3 the pharmacy will give you a lower priced interchangeable. This could be the reason that you end up getting something without the caffeine, but usually they give you a generic brand with exactly the same medicinal ingredients. There is also a very similar pain reliever called Emtec 30 which is a T3 without the caffeine. And as far as strengths of the analgesic (the 325mg of acetaminophen or 200mg of ibuprofen in a regular strength Advil) that's really all your body needs to "kill" the pain. Medicine is a funny thing, but maybe the next time you see your physician or pharmacist, ask him/her about the caffeine.
ukcommunitypharmacist

We are nice and simple in the UK. One strength of acetaminophen - 500mg (except for maybe the odd cold/flu product). Makes it nice and easy to counsel patients.

I remember a story from a few years ago of a skier who won an Olympic medal, but then failed a drug test. He had taken a cold/flu product that contained pseudoephedrine (banned by the IOC). This product was also available in the UK, but the UK product didn't contain pseudoephedrine. So if he had taken the UK product he would have kept his medal. If pharmacists and elite athletes have problems here, where does it leave average members of the public?
very cold

That is interesting that there are differences in medicine. I've been to different countries where there are different foods that are similar to what we have in the US. Oreos in South Africa have more chocolate than US oreos but medicine. I thought medicine was Universal unless there was a specific religious reason that medicine couldn't have a certain ingredient in it. Canada should have the same medicine as the US. Now I am going to have the check medicines in foreign countries to make sure i'm not allergic to the ingredients.
RJS

Actually, around 300mg (specifically 325mg) is normal for paracetamol. 500mg is considered "extra strength." For years the standard has always been 325mg, but now everyone always wants extra strength everything, so this "low" dose has gone by the wayside.

In the US, if you walk down the pain aisle, I doubt you'd see any Tylenol that's not extra strength.
ukcommunitypharmacist

Ok, so the caffeine (or lack of it) is interesting, but why on earth has it only got 300mg acetaminophen? (paracetamol to me...)

OnThePharm

Conflicting drug information from "authoritative" sources…

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