Tylenol Daily Limit

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Pharmacy Kid

Pharmacy Kid

LCDR
Verified Member
USPHS
15+ Year Member
Some of the pharmacists I work with said the FDA had decreased the daily limit of tylenol from 4g to 3g. I thought the manufacterers had changed that but it wasn't adopted by FDA yet. I couldn't find anything on the FDA web site.

Have you guys heard of anything?
 
There is no official change from the FDA as of yet, but there are many advisories against long term use of APAP over 3g/day. More specifically, APAP in combination with other pain relievers (oxycodone/hydrocodone) are being limited to a max of 325mg per pill in the fairly near future pursuant to a strong request from the DEA to drug manufactures. Abbott is poised to capitalize on this as it has reformulated its branded Vicodin to 5/300mg They are expecting patients to be stupid and pharmacists/doctors to be lazy, hence, if a doctor writes Vicodin on a script, a pharmacist technically will have to call the prescriber to get it changed to the 5/325 strength product that is less expensive.
 
Dr Wario said:
There is no official change from the FDA as of yet, but there are many advisories against long term use of APAP over 3g/day. More specifically, APAP in combination with other pain relievers (oxycodone/hydrocodone) are being limited to a max of 325mg per pill in the fairly near future pursuant to a strong request from the DEA to drug manufactures. Abbott is poised to capitalize on this as it has reformulated its branded Vicodin to 5/300mg They are expecting patients to be stupid and pharmacists/doctors to be lazy, hence, if a doctor writes Vicodin on a script, a pharmacist technically will have to call the prescriber to get it changed to the 5/325 strength product that is less expensive.
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I've been warning my prescribers about the change. Brand Vicodin has been reformulated. They can still get the old type, but must be specified. So far, I haven't had any issues. I'm expecting a lot of phone calls to the generic Norco products.
 
Dr Wario said:
There is no official change from the FDA as of yet, but there are many advisories against long term use of APAP over 3g/day. More specifically, APAP in combination with other pain relievers (oxycodone/hydrocodone) are being limited to a max of 325mg per pill in the fairly near future pursuant to a strong request from the DEA to drug manufactures. Abbott is poised to capitalize on this as it has reformulated its branded Vicodin to 5/300mg They are expecting patients to be stupid and pharmacists/doctors to be lazy, hence, if a doctor writes Vicodin on a script, a pharmacist technically will have to call the prescriber to get it changed to the 5/325 strength product that is less expensive.
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Auto sub baby. Those schinnanigans would only work in retail.
 
SpirivaSunrise said:
Yeah, this wasn't the FDA's call....

And more info from J&J.
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Yes and no. The last guidance from the FDA advisory panel was 2009. They are being proactive in an attempt to keep the Extra Strength Products on the market. You know how many facings of Tylenol go away if the 500mg goes away. They are deathly afraid of losing that market. Should the advisory panel change their mind, the 325mg limit in prescription drugs could find it's way to OTC products.

I've been at this a long time and I'm pretty good at reading the tea leaves. Look back at this thread where I predicted the demise of Narcotic du jour + Tylenol would be capped at 325 in June 2009 a good 18 months before the FDA announced.
 
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