Drugplain

butalbital and acetaminophen 300 mg/1

butalbital and acetaminophen · CAPSULE · Granules Pharmaceuticals Inc.

No Recall History
Plain English

butalbital and acetaminophen is a capsule containing butalbital and acetaminophen at 300 mg/1, taken oral. Manufactured by Granules Pharmaceuticals Inc..

Key Facts

Brand Name
butalbital and acetaminophen
Generic Name
butalbital and acetaminophen
NDC Code (Product)
70010-054
Manufacturer
Granules Pharmaceuticals Inc.
Strength
300 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
ANDA213115
Drug Class
Barbiturate [EPC]
Marketing Start
01/20/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Butalbital and acetaminophen tablets 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 50 mg/325 mg: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets. 50 mg/300 mg : One or two tablets every four hours. Total daily dosage should not exceed six tablets. 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 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. Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized e…

Contraindications

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

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. Poten…

Frequently Asked Questions

What is butalbital and acetaminophen used for?

butalbital and acetaminophen contains butalbital and acetaminophen. It is a capsule taken oral. Consult your doctor for specific uses.

Is butalbital and acetaminophen a controlled substance?

Yes, butalbital and acetaminophen is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for butalbital and acetaminophen?

The generic name for butalbital and acetaminophen is butalbital and acetaminophen. There are 10 other brand versions of butalbital and acetaminophen.

What is the NDC code for butalbital and acetaminophen 300 mg/1?

The NDC (National Drug Code) for butalbital and acetaminophen 300 mg/1 is 70010-054, listed by Granules Pharmaceuticals Inc..

Product NDC

70010-054

Package NDC

70010-054-01

Other butalbital and acetaminophen Dosages

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)