| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | TABLET;ORAL | 300MG;50MG | No | Yes |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090956-001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 300MG;50MG | TABLET / ORAL | AA | RS | 2011-08-23 |
| Application-product | TE code |
|---|---|
| A090956-001 | AA |
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| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Butalbital and Acetaminophen | BUTALBITAL AND ACETAMINOPHEN TABLETS | Oceanside Pharmaceuticals | d2213ffd-18f6-45f5-9af7-690a977562c4 | 2020-04-02 | Boxed warning, Warnings, Adverse reactions |
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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.
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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 exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. 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 and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital and Acetaminophen Tablets for patients with acetaminophen allergy.
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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: 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. Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0095-3000 | BUPAP | Butalbital and Acetaminophen Tablets | Bausch Health US, LLC | ANDA | Current |
| 0095-3000 | BUPAP | Butalbital and Acetaminophen Tablets | ECR Pharmaceuticals | ANDA | Current |
| 0095-3000 | BUPAP | Butalbital and Acetaminophen Tablets | Bausch Health Americas Inc. | ANDA | Current |
| 0095-3000 | BUPAP | Butalbital and Acetaminophen Tablets | Bausch Health US, LLC | ANDA | Current |
| 0095-3000 | BUPAP | Butalbital and Acetaminophen Tablets | Bausch Health US, LLC | ANDA | Current |
| 0722-7075 | Butalbital and Acetaminophen | Butalbital and Acetaminophen | Nexgen Pharma, Inc. | ANDA | Current |
| 0722-7075 | Butalbital and Acetaminophen | Butalbital and Acetaminophen | Nexgen Pharma, Inc. | ANDA | Current |
| 68682-306 | Butalbital and Acetaminophen | Butalbital and Acetaminophen tablets | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-306 | Butalbital and Acetaminophen | Butalbital and Acetaminophen tablets | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-306 | Butalbital and Acetaminophen | Butalbital and Acetaminophen tablets | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-306 | Butalbital and Acetaminophen | Butalbital and Acetaminophen tablets | Oceanside Pharmaceuticals | ANDA | Current |
| 79739-7075 | Butalbital and Acetaminophen | Butalbital and Acetaminophen | LGM Pharma Solutions, LLC | ANDA | Current |