Is It Illegal To Not Follow OTC Med. Directions?

Hello All,

A friend of mine takes more ibuprofen than what says on the bottle you can take during a day. However, he's NOT taking a rediculous amount, just a little bit over what the bottle says....

Is he breaking the law? I've been trying to find a link that does come out and says if you don't follow what the label says that it is truly illegal.

Anyone know if this is the case or not the case?

Thanks!

It's VERY illegal!!! oo: .... haven't you ever heard of the OTC-police? Nasty buggers in black suits... and they always come after you in black helicopters... :tinfoil:



Nothing illegal about it taking more than is stated on the bottle... but it sure as hell isn't very advisable.

jar3ds said:

Hello All,

A friend of mine takes more ibuprofen than what says on the bottle you can take during a day. However, he's NOT taking a rediculous amount, just a little bit over what the bottle says....

Is he breaking the law? I've been trying to find a link that does come out and says if you don't follow what the label says that it is truly illegal.

Anyone know if this is the case or not the case?

Thanks!

Click to expand...

It's not illegal by any means.

Actually, some conditions require FAR more ibuprofen than is "recommended" on the OTC bottle. The reason is that ibuprofen is a painkiller in small doses... but in large doses (>1500mg/day) it's a pretty potent anti-inflammatory drug.

Something you should let your friend know, however, is that ibuprofen is very harsh on your stomach, and, especially in large quantities, should not be taken without food or milk, as it will burn the stomach lining. Prolonged ibuprofen treatment can indeed cause ulcers to form if the patient takes it inappropriately.

P.S. Why does your friend take so much of it? If he's self-medicating and he needs more than the OTC bottle recommends, it's likely that he should see a doctor.

RE ibuprofen
Let's put it this way - the prescription dose is a tad more than the 1 pill, maybe 2 - My MD has told me what MY prescription does is, and said "I can write a script, or you can take the same dose in otc" - which is what I do

That said - I usually live with the 2 pills - and if I need more, I go to my Vicodin

If I remember correctly the FDA mandates (or at least approves) the recommended dosage for OTC drugs. They are based on an average since all they ever spell out is one dose for children and one for adults. It's obvious that an 80lb. person and a 280lb person would require differing amounts of some drugs to be effective.

I remember my doc giving me an Rx for 600mg of Naproxen which is exactly what is in Alleve. The Rx was actaully cheaper than me buying a bottle an taking 2 pills.

Over the counter Motrin or Advil is 200mg. Taking 2 would give you 400mg which will give you the maximum amount of pain relief. Higher doses- upto 800mg will give more anti-imflamtory effects but not help anymore with pain. As with most drugs increasing the dose will give you more side effects- mostly gastrointestinal with this class of drugs. The dose should not exceed 3200mg per day.
There is no 600mg dose of naproxen that I'm familiar with. Most commonly the dose is 500mg twice daily. Aleve is actually naproxen sodium and is most commonly dosed on prescription (as Anaprox) at 550 mg twice daily. Taking 2 Aleve ( each tablet is 220mg) would give you a perfectly acceptable dose of 440mg . The sodium salt is thought to give quicker pain relief than plain naproxen.

Sasha said:

It's VERY illegal!!! oo: .... haven't you ever heard of the OTC-police? Nasty buggers in black suits... and they always come after you in black helicopters... :tinfoil:



Nothing illegal about it taking more than is stated on the bottle... but it sure as hell isn't very advisable.

Click to expand...

Or they will try to take away your website! Sorry,I know its off topic but I couldn't resist!

Just be careful of ibuprofen in large doses. I knew a guy who took alot of ibuprofen and loved to drink red wine. After a month or so, the wine wasn't the only thing that was red.

NSAID's (Naproxen, Ibuprofen, etc) and Aspirin in high doses can result in Gastric Ulcers especially if the individual is elderly and has had a history of GI complications. Actually, studies show that as little as an 80mg baby aspirin can cause GI complications. If you need to take high doses of NSAID's, often, make sure you take them concomitantly with a PPI like OTC Prilosec or one of the others, which will reduce gastric acid and GI mucosal breakdown...

God I watch to much "ER"

Good luck,
Flavio

Want a quick pain releated, but slightly OT story?

Yesterday - Dad calls me at 5:45am - he's in a lot of pain (pelvic arthritis) - wants me to call the amulance - only reason I did so if I found out he MIGHT have taken too many tylenol (we figured out he took 3..) All and all, not a BIG deal, BUT...

Somewhere in conversation, I call the ambulance a "bus" (at least in NYC, that is the insider slang) - when we got Dad loaded, the one of the EMTs looked at me and said "what do you do for a living?" I told him a computer programmer, why? He said you called the ambulance a bus, which NO ONE does - and when we hear that, we wonder. I smiled, and said that I used to do a bunch of Vol work with the Red Cross and Salvation Army, so have spent a LOT of time hanging with MOS... He laughed

At work we call Advil/Ibuprofen "UPS candy" (I work at UPS) since many of us take it like candy for the daily aches and pains due to the hard work we do. During the busier times of the years I'll often take two before starting work as "preventative maintenance" and take another two or three 2-3 hours later if I still have some nagging pain. I typically don't over-medicate though, and will many times just live with some pain than take anything for it. If I hurt my back at work and have severe pain that lasts several days I'll often use prescription muscle relaxants and/or anti-inflammatory medication, but if I'm out, I'll just increase my Ibuprofen to 800mg at a time. Never had any problems with all the Ibuprofen I take. I usually buy bottles of 500 caplets two or three times a year. I'm a big guy though at 6'1" and 240 lbs, so 800mg isn't going to affect me like it will my sister who is 4'11" and 100 lbs.

NeonLights said:

At work we call Advil/Ibuprofen "UPS candy" (I work at UPS)...

Click to expand...

"Vitamin M" to my Army buddies

But, back to to original question, I think you may be remembering the "illegal to use in a manner inconsistent with label directions" type warning you see on a lot of consumer hazmat like insecticides, herbicides, etc.

Cheers,
Bob

BobVA said:

"Vitamin M" to my Army buddies

Click to expand...

We called it "Ranger Candy".

Last year when I broke my ankle I was taking two 800 mg pills twice daily. One of the Cardiologists I worked said it would be okay for a short time (6 weeks max IIRC). More problematic than the GI related issues is the effects of long-term high dose use on your liver and kidneys. That was his concern.

My use was more for anti-inflammatory than pain relief.

I disagree with this at least from a personal experience. When I have a real mean headache, sometimes from alcohol abuse, sometimes 400mg isn't enough so after a half hour if I don't get relief from 400mg, I'll take 400mg more and that seems to do the trick. I'm not a real big, overweight guy either. When I've had injuries, I've taken up to 2400mg a day per doctor's prescription except I never fill the prescription as 200mg OTC generic pills are dirt cheap. Ibuprofen is a godsend.

Ronrph said:

Over the counter Motrin or Advil is 200mg. Taking 2 would give you 400mg which will give you the maximum amount of pain relief. Higher doses- upto 800mg will give more anti-imflamtory effects but not help anymore with pain.

Click to expand...

geepondy said:

When I've had injuries, I've taken up to 2400mg a day per doctor's prescription except I never fill the prescription as 200mg OTC generic pills are dirt cheap. Ibuprofen is a godsend.

Click to expand...

From what I remember from Pharmocology (been awhile) it's easier for the body to break down, and the drug has a higher efficacy when using one pill of a higher dosage than multiple lower dosage pills.

Also with a half way decent prescription plan you can get up to a 30 day supply of 800 mg IBUs for $5.00.

swampgator said:

Also with a half way decent prescription plan you can get up to a 30 day supply of 800 mg IBUs for $5.00.

Click to expand...

The several times my doctor has prescribed 800mg of Ibuprofen, I always get it filled since generics are free under my insurance plan.

Be careful with prolonged high doses of Ibuprofen. One day my Mom called me and told me she had fallen down.. LOng story short she had fainted from bleeding into her stomach.. You guessed it. long term hi dose of Ibuprofen...

UncleFester said:

Be careful with prolonged high doses of Ibuprofen. One day my Mom called me and told me she had fallen down.. LOng story short she had fainted from bleeding into her stomach.. You guessed it. long term hi dose of Ibuprofen...

Click to expand...

Sorry to hear that. I hope your mother was/will be ok. Just out of curiosity, how long had she been taking high doses of Ibuprofen and how much per dose and per day?

Speaking of pharmaceuticals, don't you "love" it when you're getting a prescription filled and the dialog goes something like this:

Pharm helper: The Pharmacist must speak with you.
(wait 10 more minutes)

Pharm: Have you taken this medication before?
Me: No, ma'm, it's for my kid.
Pharm: Ah, I see. Has he taken this before?
Me: Yes, ma'm. He's had recurring XYZ and we know the drill.
Pharm: Oh, so you know how to administer this medication.
Me: Yes, ma'm, thank you, I don't need you to read the instructions out loud.
Pharm: Ah, OK. (looks at the bottle) So it says here to give him XYZ 3 times a day.
Me: Yes, ma'm I know that.
Pharm: It's best if you time those so he takes them with meals.
Me: (forced smile) Yes, ma'm, we've been doing this for a while.
Pharm: Do you have any questions?
:shakehead

...at this point I'm about to :hairpull: It's the same pharmacist (small town, we know each other), the same meds, the third time I've been in there to have the same meds filled, and more or less the same routine *every* single time!

I'm sure pharmacists take a "don't listen to what the person on the other side of the counter tells you and read the label anyway 315" while in college. :scowl:

UncleFester said:

Be careful with prolonged high doses of Ibuprofen. One day my Mom called me and told me she had fallen down.. LOng story short she had fainted from bleeding into her stomach.. You guessed it. long term hi dose of Ibuprofen...

Click to expand...

I hope your mom is ok and recovering from that...

My point exactly...NSAID induced Gastric Ulcers are serious. If I recall the statistic correctly, I believe deaths resulting from NSAID induced GI complications ranked #14 just above AIDS/HIV.

People take them like candy because if it's an OTC then it must be safe right?

I believe if the FDA, today, was reviewing NSAID's for a NDA(new drug application) they would not approve them for use in the USA.