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Why Fioricet is not controlled but Fiorinal is controlled ?

Fioricet medicine is a popular brand name for a blend of three drugs, which comprise of caffeine, butalbital and acetaminophen.

Fioricet Blue
Fioricet Blue

The combination of these three drugs is used to treat migraines, tension headaches and different types of other pain ailments. Fioricet is not clearly labeled as a common pain reliever. The medicine is  available only with your doctor’s prescription, but if you are suffering from tension headache, it is better to speak to your doctor about the effects of using Fioricet to manage serious or recurring headaches.

Fioricet was approved by FDA in 1984 and Novartis Pharmaceuticals was its original manufacturer. In 2003, Watson pharmaceuticals now known as Actavis, purchased the rights to sell Fioricet. Many manufacturers are now selling Fioricet in generic form as well. The original formulation of the medicine included

  • 50 milligrams butalbital
  • 40 mg of caffeine
  • 320 mg – acetaminophen

Mechanism of formulation

Butalbital is a type of sedative used as a muscle relaxer in Fioricet, the butalbital is used to alleviate the muscle tension that occurs due to tension headaches. One should take Fioricet as prescribed by the doctor and should avoid the dependency on drug. Do not exceed the recommended dose.

Caffeine is used in Fioricet to improve the efficacy of acetaminophen. When taking Fioricet, the patients should not take substances that contain caffeine to avoid overdose and nervousness caused by high consumption of caffeine.

Acetaminophen is a popular pain reliever, which is also available   over the counter. Since acetaminophen is easily available, the patients taking Fioricet should be familiar with the contents of any other medications, they are using to prevent overdose.

According to FDA guidelines, the manufacturers are recommended to restrict the dose of acetaminophen in different prescription products.

Fioricet plus codeine

Another formula which includes Fioricet and codeine is also discovered by Actavis to deal with tension headaches. It comprises of 30 mg- codeine along with other 3 drugs and contains increased dose of acetaminophen, which is 325mg.

The Fioricet plus codeine comes in a black box with a warning about how it can be toxic for your liver, lead to respiratory problems and death in kids caused by codeine.

Addiction and Abuse

In Fioricet, the sedative known as butalbital is present, which belongs to the class of certain drugs known as barbiturates, a depressant that can affect your central nervous system. It has the ability to cause psychological and physical dependence which can result in abuse.

Those who take too much medicine (Fioricet) may discover that they are stress free and feel relaxed. This makes them addictive to the drug as they start taking high doses to get the satisfactory results.  Some people say that they feel intoxicated. However, people can get into depression once the effect of medicine goes off.

Despite of its risks, Fioricet is an effective medicine to manage migraines and tension headaches. When used under the supervision of an experienced doctor and when taken as prescribed by the doctor can help people get great results.

Is it legal to buy Fioricet and Gabapentin Online ?

Yes, it is Legal to buy certain prescription drugs online if they are located and Licensed in the USA. The questionaire is what the Doctor needs to know BEFORE giving you a prescription. To just write out prescriptions would be illegal.

Fioricet and gabapentin are not controlled subsctance, so it is Ok to get your orders online. But you must complete your questionnaires very carefully and honestly. Your IP address also maybe reordered to check whether you are a legal US nature man or woman.

Controlled substances are not allowed online. But some countries controlled some medicines but some other countries even list it as over the counter medicines. You must follow your own country’s law.

How should I take Fioricet ?

Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the medicine with food or milk if it upsets your stomach.

Store Fioricet at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

Why Fioricet is not Controlled but Fiorinal is controlled ?

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.  The max dose of acetaminophen per day is 4000 mg, and since there’s only 325 mg in Fioricet, you’ll have to take a lot at once or take them for a long time to get the damage from acetaminophen, whereas someone on warfarin takes aspirin and isn’t aware of it the effects could be immediate….The fatal liver damage from acetaminophen comes when you take it with alcohol, so if you don’t take your Fioricet with a shot you should be ok at this dose

Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal is scheduled because drug abusers can easily perform an “acid wash” to remove the aspirin (acetylsalicylic acid) component. It is much more difficult to remove the acetaminophen component in Fioricet. 

The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.

The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.

Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act2. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.

The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling1. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

Citation: Section 811(g)(3)(A) Controlled Substances Act

**Please note: Under the following states law, Fioricet is classified as a Schedule III controlled drug. **

  1. Georgia
  2. Maryland
  3. New Mexico

 Alabama Pharmacy State Board Newsletter that gives somewhat of an explanation:

In the past, there has been confusion over the controlled status of Fioricet. Fioricet is not scheduled federally. In 1980, a federal panel set forth criteria to except certain compounds if they were combined with butalbital and fell within the proper ratio of acetaminophen and butalbital. Fioricet met the criteria to be an excepted compound and was excepted in 1980.

Fiorinal is a much older drug than Fioricet and was released at a time when all butalbital-containing drugs were listed as Schedule-III. Butalbital was later removed from that listing but brand name Fiorinal was never taken off of the list. Fioricet came along after butalbital was removed from the list and it therefore carries no control status. However, butalbital does still carry some danger of dependence and there is no difference in the dependence levels between butalbital with aspirin and butalbital with acetaminophen.

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