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label for Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg 100 tablet label.

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Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substances Act (CSA).

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People who suffer from tension-type headaches that do not respond to over-the-counter (OTC) medications may find relief with combination drugs that include butalbital. Commonly prescribed as Fioricet (butalbital/acetaminophen/caffeine) or Fiorinal (butalbital/aspirin/caffeine), butalbital is a sedative in the barbiturate class of medicines. Although the drug causes intense relaxation and eases the pain of a tension headache, it is not without risks.

Fioricet (butalbital / acetaminophen / caffeine) is a combination of three medications. Butalbital is a barbiturate that relaxes you. Acetaminophen relieves pain, and caffeine narrows the blood vessels that contribute to headaches.

Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

This medicine is available only with your doctor’s prescription.

This combination of drugs is used to relieve tension headaches. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Fioricet is a brand-name analgesic, and it’s used to treat tension headaches. The active ingredients are acetaminophen (pain reliever), caffeine (enhances effects of acetaminophen), and butalbital (sedative). You might have a tension headache if you have a dull pain, tightness, or pressure across your forehead or in the back of your head and neck. They can last as long as 30 minutes to several days. A chronic case could result in headaches lasting for 60 to 90 days. Although tension headaches are common in adults, only 3% have chronic tension headaches on a daily basis.

Your healthcare provider will determine the best medication and dosage for your tension headaches based on the severity and duration of your headaches, your medical history, and current list of medications.

Fioricet Detox

Fioricet is known to have withdrawal symptoms when regular use is discontinued. These symptoms can decrease gradually over an estimated two-week period.  However, the safest way to proceed through withdrawal from Fioricet requires medical assistance, as withdrawal symptoms from Fioricet can be fatal if they are not properly supervised.

Detoxification is the body’s natural process of removing toxins. People who frequently use a substance never truly detoxify from the substance because they are always adding more into their system. When someone with a Fioricet use disorder chooses to seek treatment, the first thing they must do is stop taking Fioricet and let the body detoxify.

The detoxification process can be challenging, but it is a necessary part of a person’s recovery. A medically supervised detox program is important to safely remove the substance from the body. Some people choose to try “cold turkey” detoxification, which is a potentially dangerous detox approach that involves an individual abruptly halting the intake of the drug. Because of the sudden lack of the substance that the body and mind have become used to, a person can experience severe withdrawal symptoms that often result in a failed attempt at detoxing. Quitting Cold Turkey is not a recommended or an efficient way to detox from Fioricet.

There is not one specific detoxification program that works the same for everyone. To meet individual needs, The Recovery Village has staff and resources to tailor a detox approach for each client’s unique needs. At a rehabilitation facility, trained medical professionals will guide each patient through their unique treatment plan and usher them safely through their personal withdrawal symptoms.

Detox Process for Fioricet Abuse

There are two ways to detox: “cold turkey”, or by tapering, which is gradually lowering substance dosages. Many people who choose to detox on their own at home attempt the “cold turkey” method. However, a cold-turkey detox can be dangerous, because the onset of withdrawal symptoms is more severe. Because of the potential intensity of Fioricet withdrawal symptoms, the person going through detox may end up experiencing setbacks without the proper supervision and care that a rehabilitation facility can provide.

Professional medical detoxification is the safest option when it comes to beginning on the path to recovery. At The Recovery Village, clients are monitored 24/7 to ensure that withdrawal is as comfortable as possible, that their vitals are at healthy levels and that they are not experiencing any life-threatening symptoms.

The primary risks during detox include dehydration and delirium tremens. Severe dehydration can lead to seizures,, which can easily become lethal, especially if they occur in an at-home environment without medical supervision. Delirium tremens can also lead to cardiac arrhythmia and respiratory failure, which can be fatal if left untreated.

Following detox, the patient is ready to begin treatment for their Fioricet use disorder. The Recovery Village offers many different treatment options including inpatient and outpatient rehab. Rehab is a proven treatment method for Fioricet addiction because it addresses both the physical and psychological sides of the disease.

Fioricet Detox Medications

Some rehab facilities may offer medically assisted detox. A medically assisted detox is supervised detoxification, using a substitute substance. There are several substitute substances available including suboxone, methadone, and benzodiazepines. Overall, the average medically assisted detox lasts between three and seven days, depending on the individual circumstances.

The most common substitute substances used during medically assisted detoxification are suboxone and methadone. The main advantage of a medically assisted detox is the reduction in  severity of withdrawal symptoms. A Fioricet withdrawal —among withdrawals from most substances —is an uncomfortable experience and it is often the desire to avoid these symptoms that encourages people to keep taking the substance.

Medical detox is only the first step of an addiction rehabilitation program. After a client completes withdrawal from Fioricet, it is encouraged that they go through some kind of rehabilitation program.

Fioricet Detox Centers

Undergoing withdrawal symptoms in a professional treatment center can make the entire process significantly safer. While no Fioricet-specific detox centers exist, there are a number of options available to help people detox from barbiturates or other substances. In a formal medical detox setting, clients can have access to care that addresses both the physical and psychological symptoms of withdrawal, all with 24/7 supervision from a team of physicians and clinicians.

If you or someone you love struggles with a Fioricet use disorder, comprehensive detox centers are available to provide care during their treatment. A leading behavioral health care provider, The Recovery Village provides clients with a full continuum of substance use disorder treatments, including medical detox. Withdrawal can be tough, but outlasting the symptoms is worth it. The Recovery Village has a dedicated team of professionals ready to help you or a loved one begin detoxification and addiction recovery.

Tension Headaches and Butalbital 

The most common type of headache disorder, a tension headache occurs when neck and scalp muscles become tense, or contract, meaning they squeeze down. This causes pain, often described as a rubber-band-around-the-head feeling or a pressure sensation, on both sides of the head. Tension headaches can be triggered by a number of factors including stress, hunger, lack of sleep, anxiety, and temperature changes. They may occur at any age but are most common in adults and older teens. Some people are more prone or vulnerable to developing tension headaches than others, although the reason behind this is not very clear.

Most tension headaches are mild in pain and can be easily alleviated with rest, fluids, removal of the trigger, and/or an over-the-counter medication like Motrin (ibuprofen) or Tylenol (acetaminophen). Behavioral therapies too can be effective like physical therapy or cognitive-behavioral therapy.

Butalbital

When recurring tension headaches do not respond to other treatments, your doctor may prescribe Fiorinal or Fioricet. Codeine may also be added to this combination of medicine. While this medication is very effective in the short-term, there are some things to watch out for.

  • Are allergic to any ingredients in the medication, such as acetaminophen or aspirin.
  • Are currently taking blood thinners, antidepressants, antihistamines, or other sedatives such as sleeping pills or tranquilizers
  • Have or previously had liver disease, porphyria, or depression
  • Are pregnant, plan to become pregnant, or are currently breastfeeding

How should this medicine be used?

The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.

This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

What special precautions should I follow?

  • Fioricet (butalbital / acetaminophen / caffeine) works better and faster in treating tension headaches than the combination of acetaminophen and codeine.
  • Fioricet (butalbital / acetaminophen / caffeine) has a cheaper, generic version.
  • Fioricet (butalbital / acetaminophen / caffeine) does not require dosage adjustments if you have kidney and liver problems.
  • Fioricet (butalbital / acetaminophen / caffeine) isn’t the first choice medication for treating tension headaches.
  • Fioricet (butalbital / acetaminophen / caffeine) is not a good medication for long-term use.
  • Overuse of Fioricet (butalbital / acetaminophen / caffeine) can lead to chronic tension headaches.
  • Fioricet (butalbital / acetaminophen / caffeine) can cause dangerous withdrawal symptoms, intoxication, and dependence.
  • Taking Fioricet (butalbital / acetaminophen / caffeine) can decrease your ability to drive a car, or operate machinery.

Before taking acetaminophen, Butalbital, Caffeine,

  • tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants (‘blood thinners’) such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
  • tell your doctor if you have or have ever had liver disease, porphyria, or depression.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
  • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
  • remember that alcohol can add to the drowsiness caused by this drug.

What special dietary instructions should I follow?

Acetaminophen, Butalbital, Caffeine may cause an upset stomach. Take this medicine with food or milk.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Side effect rates for Fioricet (butalbital / acetaminophen / caffeine)

If you experience any of the following symptoms, call your doctor immediately:

  • skin rash
  • itching
  • difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Intoxication

Butalbital slows the central nervous system, leading to lack of coordination, problems with thinking and memory, slowness of speech, disinhibition, and emotional disturbances. Do not drive or operate heavy machinery while taking medicines containing butalbital.

Fioricet (butalbital / acetaminophen / caffeine) contains acetaminophen, also known as Tylenol or APAP. Taking too much acetaminophen causes liver damage that can be permanent and life-threatening. Using more than 4000 mg of the acetaminophen can cause serious harm to your liver, so be sure not to take more than the recommended dose of Fioricet (butalbital / acetaminophen / caffeine) or other medications that contain acetaminophen.

Medication Overuse Headache

A medication-overuse headache (MOH), once known as a rebound headache, drug-induced headache, or medication-misuse headache, is a chronic headache that develops as a result of prolonged and frequent use of certain medications for acute headaches. Such headaches are a common side effect of a number of classes of medications used to treat headaches.

According to the International Classification of Headache Disorders, MOH is diagnosed when a person has a headache 15 or more times a day and, in the case of combination pain relievers like Fioricet and Fiorinal, has been taking the drug for 10 days a month for more than three months.

In addition, medication overuse headaches are often not responsive to preventive headache medications. This lack of response to other medications is often a clue to doctors that a medication overuse headache has developed.

Medications containing butalbital should be limited to two days per week to avoid this rebound effect.7

Withdrawal

When taking butalbital, you may experience withdrawal symptoms within eight to 36 hours after the last dose. Withdrawal symptoms may include anxiety, muscle twitching, tremor, weakness, dizziness, nausea and vomiting, insomnia, weight loss, and even seizures when the medication is discontinued.

Due to the risk of seizures with a withdrawal from butalbital, medical treatment in a monitored setting under the care of a physician is indicated.

Tolerance and Addiction

Tolerance and addiction may also occur with butalbital. Tolerance means that a person needs more of the medication to achieve headache relief. Addiction to butalbital is characterized by persistent behaviors, like compulsions, to take a butalbital-containing medication.

These behaviors impair their life in some way, negatively impacting relationships and/or everyday functioning.

Acetaminophen Overdose

Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Alagesic®
  • Americet®
  • Anolor®
  • Anoquan®
  • Arcet®
  • Dolgic®
  • Dolmar®
  • Endolor®
  • Esgic®
  • Ezol®
  • Femcet®
  • Fioricet®
  • Fiorpap®
  • G-1®
  • Ide-cet®
  • Isocet®
  • Margesic®
  • Medigesic®
  • Minotal®
  • Mygracet®
  • Nonbac®
  • Pacaps®
  • Pharmagesic®
  • Quala Cet®
  • Repan®
  • Tenake®
  • Tencet®
  • Triad®
  • Two-Dyne®
  • Zebutal®

Brand names of combination products

  • Esgic® Plus (containing Acetaminophen, Butalbital, Caffeine, Codeine)
  • Geone® (containing Acetaminophen, Butalbital, Caffeine)¶
  • Orbivan® (containing Acetaminophen, Butalbital, Caffeine)¶
  • Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
  • Phrenilin® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)

¶This branded product is no longer on the market. Generic alternatives may be available.

Last Revised – 05/15/2019

Fioricet drug abuse and dependence

abuse and dependence

Butalbital

Barbiturates may be habit-forming:

Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

What to avoid

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

Overdosage

Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Overdosage signs and symptoms

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

treatment

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

dosage and administration

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

how supplied

Butalbital, Acetaminophen and Caffeine Tablets, USP

Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed “2355” on one side, and debossed “V” on the reverse side.

  • Bottles of 60: NDC 0603-2544-20
  • Bottles of 90: NDC 0603-2544-02
  • Bottles of 100: NDC 0603-2544-21
  • Bottles of 500: NDC 0603-2544-28
  • Bottles of 1000: NDC 0603-2544-32

store and dispense

Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP.

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

8181466
Revised: 03/17
R9

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Image of the label for Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg 100 tablet label.
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0603-2544
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
CROSPOVIDONE
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 2355;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-2544-02 90 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 08/27/2003
2 NDC:0603-2544-20 60 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 08/27/2003
3 NDC:0603-2544-21 100 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 08/27/2003
4 NDC:0603-2544-28 500 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 08/27/2003
5 NDC:0603-2544-32 1000 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 08/27/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040511 08/27/2003
Labeler – Par Pharmaceutical (011103059)
Establishment
Name Address ID/FEI Business Operations
Vintage Pharmaceuticals, LLC 825839835 ANALYSIS(0603-2544), LABEL(0603-2544), MANUFACTURE(0603-2544), PACK(0603-2544)

Revised: 4/2017

Document Id: 4b4f3ae4-9257-437f-971b-ebe32cff30e6
Set id: aedc5167-cc3c-4044-87fa-4ed648c9f23f
Version: 14
Effective Time: 20170419

 

Par Pharmaceutical

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