Butalbital, acetaminophen and caffeine (Fioricet)are supplied in capsule form for oral administration.
Each capsule contains:
Butalbital ……………….. 50 mg
Warning: May be habit-forming.
Acetaminophen ………. 325 mg
Caffeine …………………. 40 mg
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
Fioricet is a prescription pain medicine used to treat the symptoms of tension headache.
Fioricet may be used alone or with other medications.
Fioricet is an analgesic barbiturate combo.
It is not known if Fioricet is safe and effective in children younger than 12 years of age.
What are the possible side effects of Fioricet?
Fioricet may cause serious side effects including:
-
-
- suddenly appearing rash,
- swelling of face, mouth or throat,
- difficulty breathing,
- vomiting ,
- hives,
- itching ,
- fever,
- diarrhea,
- dark colored urine,
- yellowing of eyes and skin (jaundice),
- headache,
- nausea,
- stomach pain,
- weight loss,
- white or gray stool,
- fatigue,
- dehydration ,
- abdominal upset,
- skin changes,
- sudden high blood pressure, and
- convulsions (seizures),
-
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Fioricet include:
-
- drowsiness,
- lightheadedness,
- dizziness,
- shortness of breath,
- nausea,
- vomiting,
- abdominal pain, and
- feeling intoxicated
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Fioricet. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Information For Patients /Caregivers
-
- Do not take Esgic® Capsules if you are allergic to any of its ingredients.
- If you develop signs of allergy such as a rash or difficulty breathing, stop taking Esgic® Capsules and contact your healthcare provider immediately.
- Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
How is Fioricet Used ?
Fioricet is typically used to treat tension headaches and certain types of migraines. It is a combination medication that contains three active ingredients: acetaminophen, butalbital, and caffeine. Here’s how Fioricet is typically used:
- Dosage: Fioricet comes in tablet or capsule form, and the dosage may vary depending on the specific formulation and the severity of the headache being treated. The typical adult dosage of Fioricet is one to two tablets or capsules every four hours as needed, not to exceed six tablets or capsules in a 24-hour period.
- Administration: Fioricet should be taken orally with a full glass of water. It can be taken with or without food, although taking it with food or milk may help reduce the risk of stomach upset.
- Timing: Fioricet is usually taken at the onset of headache symptoms or as directed by a healthcare provider. It is important to take Fioricet as soon as possible after the onset of symptoms to maximize its effectiveness in relieving headache pain.
- Frequency of use: Fioricet is intended for short-term use to relieve acute headache symptoms. It should not be used for more than a few days in a row, as prolonged or excessive use can lead to tolerance, dependence, and rebound headaches.
- Avoiding overuse: To minimize the risk of medication overuse headaches or rebound headaches, it’s important to use Fioricet only as needed and to avoid using it more frequently or at higher doses than prescribed. If headaches persist or worsen despite Fioricet use, consult with a healthcare provider for further evaluation and management.
- Monitoring for side effects: While Fioricet can be effective in relieving headache pain, it can also cause side effects, including drowsiness, dizziness, nausea, vomiting, and stomach upset. Monitor for any adverse reactions while taking Fioricet and contact a healthcare provider if you experience severe or persistent side effects.
- Interaction with other medications: Fioricet may interact with certain medications, including other pain relievers, sedatives, muscle relaxants, antidepressants, and medications containing acetaminophen. It’s important to inform your healthcare provider about all medications, supplements, and herbal remedies you are taking to avoid potential interactions.
- Storage: Store Fioricet at room temperature away from moisture, heat, and light. Keep it out of reach of children and pets, and dispose of any unused medication properly according to local regulations.
Always use Fioricet as directed by a healthcare provider and follow the recommended dosage instructions to ensure safe and effective treatment of tension headaches or migraines. If you have any questions or concerns about how to use Fioricet, consult with a healthcare provider for personalized guidance.