Drugplain

Butalbital, Acetaminophen, and Caffeine 325 mg/1

Butalbital, Acetaminophen, and Caffeine · TABLET · NuCare Pharmaceuticals, Inc.

No Recall History
Plain English

Butalbital, Acetaminophen, and Caffeine is a tablet containing butalbital, acetaminophen, and caffeine at 325 mg/1, taken oral. Manufactured by NuCare Pharmaceuticals, Inc..

Key Facts

Brand Name
Butalbital, Acetaminophen, and Caffeine
Generic Name
Butalbital, Acetaminophen, and Caffeine
NDC Code (Product)
68071-3249
Manufacturer
NuCare Pharmaceuticals, Inc.
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
ANDA200243
Drug Class
Barbiturate [EPC]; Central Nervous System Stimulant [EPC]
Marketing Start
09/13/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache175 reports
completed suicide153 reports
nausea138 reports
toxicity to various agents137 reports
drug ineffective136 reports
fatigue119 reports
pain112 reports
migraine101 reports
diarrhoea98 reports
dizziness79 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Dosage & Administration

DOSAGE AND ADMINISTRATION 1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Warnings

WARNINGS Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity Acetaminophen 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 high 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. Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exa…

Contraindications

CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.

Drug Interactions

Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Adverse Reactions

ADVERSE REACTIONS Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation. Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis. Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potent…

Frequently Asked Questions

What is Butalbital, Acetaminophen, and Caffeine used for?

Butalbital, Acetaminophen, and Caffeine contains Butalbital, Acetaminophen, and Caffeine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Butalbital, Acetaminophen, and Caffeine a controlled substance?

Yes, Butalbital, Acetaminophen, and Caffeine is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Butalbital, Acetaminophen, and Caffeine?

The generic name for Butalbital, Acetaminophen, and Caffeine is Butalbital, Acetaminophen, and Caffeine. There are 7 other brand versions of Butalbital, Acetaminophen, and Caffeine.

What is the NDC code for Butalbital, Acetaminophen, and Caffeine 325 mg/1?

The NDC (National Drug Code) for Butalbital, Acetaminophen, and Caffeine 325 mg/1 is 68071-3249, listed by NuCare Pharmaceuticals, Inc..

Product NDC

68071-3249

Package NDC

68071-3249-0

Other Butalbital, Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)