Butalbital And Acetaminophen

Aace Pharmaceuticals, Inc.
Human Prescription Drug
NDC 71406-109

Butalbital And Acetaminophen is a human prescription drug labeled by 'Aace Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Butalbital And Acetaminophen is 71406-109. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Butalbital And Acetaminophen drug includes Acetaminophen - 300 mg/1 Butalbital - 50 mg/1 . The currest status of Butalbital And Acetaminophen drug is Active.

Drug Information:

Drug NDC:	71406-109
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Butalbital And Acetaminophen
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Butalbital And Acetaminophen
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aace Pharmaceuticals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACETAMINOPHEN - 300 mg/1 BUTALBITAL - 50 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	07 Oct, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA214955
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	AACE Pharmaceuticals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1249617
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175693 M0002177
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	362O9ITL9D KHS0AZ4JVK
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Barbiturate [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Barbiturates [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Barbiturate [EPC] Barbiturates [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
DEA Schedule:	CIII
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
71406-109-03	30 TABLET in 1 BOTTLE (71406-109-03)	07 Oct, 2021	N/A	No
71406-109-05	500 TABLET in 1 BOTTLE (71406-109-05)	07 Oct, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Product Elements:

Butalbital and acetaminophen butalbital and acetaminophen butalbital butalbital acetaminophen acetaminophen white to off white biconvex s;8

Boxed Warning:

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.

Indications and 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.

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 Read more...

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.

Dosage and Administration:

Dosage and administration butalbital and acetaminophen tablets 50 mg/300 mg: one or two tablets every four hours. total daily dosage should not exceed 6 tablets. extended and repeated use of these products is not recommended because of the potential for physical dependence.

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: 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 to Read more...

xic 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.

Overdosage:

Overdosage following an acute overdosage of butalbital and acetaminophen, toxicity may result from the barbiturate or the acetaminophen. signs and symptoms toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock. in acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. renal tubular necroses, hypoglycemic coma, and coagulation defects may also occur. early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. treatment a single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. assisted or controlled ventilation should also be considered. gastric decontamination with activated charcoal should be administered just prior to n-acetylcysteine (nac) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. to obtain the best possible outcome, nac should be administered as soon as possible where impending or evolving liver injury is suspected. intravenous nac may be administered when circumstances preclude oral administration. vigorous supportive therapy is required in severe intoxication. procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Description:

Description each butalbital and acetaminophen tablet for oral administration, contains butalbital, usp 50 mg, acetaminophen, usp 300 mg. in addition, each butalbital and acetaminophen tablet contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, povidone, and stearic acid. butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. it has the following structural formula: c11h16n2o3 molecular weight = 224.26 acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. it has the following structural formula: c8h9no2 molecular weight = 151.16 acetaminophen structure butalbital structure

Clinical Pharmacology:

Clinical pharmacology this combination drug product is intended as a treatment for tension headache. it consists of a fixed combination of butalbital and acetaminophen. the role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood. pharmacokinetics: the behavior of the individual components is described below. butalbital: butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. barbiturates in general may appear in breast milk and readily cross the placental barrier. they are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility. elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. the plasma half-life is about 35 hours. urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxy-propyl) barbituric Read more...

acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. of the material excreted in the urine, 32% is conjugated. see overdosage for toxicity information. acetaminophen: acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. the plasma half-life is 1.25 to 3 hours but may be increased by liver damage and following overdosage. elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. see overdosage for toxicity information.

How Supplied:

How supplied white to off white, round-shaped, biconvex tablets debossed âs8â on one side and plain on the other side, in bottles of 30 (ndc 71406-109-03) and in bottles of 500 (ndc 71406-109-05). each tablet contains butalbital, usp 50 mg and acetaminophen, usp 300 mg. store at 20Â°c to 25Â°c (68Â°f to 77Â°f) [see usp controlled room temperature]. dispense in a tight container as defined in the usp. manufactured by: aace pharmaceuticals, inc., fairfield, nj 07004 usa rev. 00, 10/21

Package Label Principal Display Panel:

Principal display panel 30 count container label 500 count container label 30 count container label 500 count container label

Comments/ Reviews:

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