Butalbital, Acetaminophen, Caffeine
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- BUTALBITAL, ACETAMINOPHEN, CAFFEINE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- BUTALBITAL, ACETAMINOPHEN, CAFFEINE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- BUTALBITAL, ACETAMINOPHEN, CAFFEINE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
HepatotoxicityAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
BUTALBITAL, ACETAMINOPHEN, CAFFEINE DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacokinetics
Butalbital
OVERDOSAGE
Acetaminophen
OVERDOSAGE
Caffeine
OVERDOSAGE
INDICATIONS & USAGE
BUTALBITAL, ACETAMINOPHEN, CAFFEINE CONTRAINDICATIONS
WARNINGS
HepatotoxicityAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Hypersensitivity/anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Butalbital, Acetaminophen and Caffeine Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets, USP for patients with acetaminophen allergy.
PRECAUTIONS
GeneralINFORMATION FOR PATIENTS
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● Do not take Butalbital, Acetaminophen and Caffeine Tablets, USP if you are allergic to any of its ingredients.
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● If you develop signs of allergy such as a rash or difficulty breathing stop taking Butalbital, Acetaminophen and Caffeine Tablets, USP and contact your healthcare provider immediately.
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● Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
LABORATORY TESTS
DRUG INTERACTIONS
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsNonteratogenic Effects
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
BUTALBITAL, ACETAMINOPHEN, CAFFEINE ADVERSE REACTIONS
Frequently ObservedInfrequently Observed
The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in theOVERDOSAGEsection.
DRUG ABUSE AND DEPENDENCE
Abuse and DependenceButalbital
OVERDOSAGE
Signs and Symptoms
barbiturate
acetaminophen
caffeine
Treatment
DOSAGE & ADMINISTRATION
HOW SUPPLIED
Butalbital, Acetaminophen and Caffeine Tablets, USPSTORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, Caffeine TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
