Acetaminophen And Codeine Phosphate

Aphena Pharma Solutions - Tennessee, Llc
Human Prescription Drug
NDC 67544-002

Acetaminophen And Codeine Phosphate is a human prescription drug labeled by 'Aphena Pharma Solutions - Tennessee, Llc'. National Drug Code (NDC) number for Acetaminophen And Codeine Phosphate is 67544-002. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Acetaminophen And Codeine Phosphate drug includes Acetaminophen - 300 mg/1 Codeine Phosphate - 30 mg/1 . The currest status of Acetaminophen And Codeine Phosphate drug is Active.

Drug Information:

Drug NDC:	67544-002
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:	Acetaminophen And Codeine Phosphate
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:	Acetaminophen And Codeine Phosphate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aphena Pharma Solutions - Tennessee, Llc
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 CODEINE PHOSPHATE - 30 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:	06 Jul, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	02 Jan, 2026
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:	ANDA040419
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:	Aphena Pharma Solutions - Tennessee, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	993770 993781 993890
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.
UNII:	362O9ITL9D GSL05Y1MN6
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:	Full Opioid Agonists [MoA] Opioid Agonist [EPC]
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
67544-002-09	9 TABLET in 1 BOTTLE, PLASTIC (67544-002-09)	06 Jul, 2011	N/A	No
67544-002-15	15 TABLET in 1 BOTTLE, PLASTIC (67544-002-15)	06 Jul, 2011	N/A	No
67544-002-20	20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)	06 Jul, 2011	N/A	No
67544-002-30	30 TABLET in 1 BOTTLE, PLASTIC (67544-002-30)	06 Jul, 2011	N/A	No
67544-002-40	40 TABLET in 1 BOTTLE, PLASTIC (67544-002-40)	06 Jul, 2011	N/A	No
67544-002-45	45 TABLET in 1 BOTTLE, PLASTIC (67544-002-45)	06 Jul, 2011	N/A	No
67544-002-46	56 TABLET in 1 BOTTLE, PLASTIC (67544-002-46)	28 Jul, 2021	N/A	No
67544-002-50	50 TABLET in 1 BOTTLE, PLASTIC (67544-002-50)	06 Jul, 2011	N/A	No
67544-002-53	60 TABLET in 1 BOTTLE, PLASTIC (67544-002-53)	06 Jul, 2011	N/A	No
67544-002-54	84 TABLET in 1 BOTTLE, PLASTIC (67544-002-54)	04 Aug, 2021	N/A	No
67544-002-55	75 TABLET in 1 BOTTLE, PLASTIC (67544-002-55)	06 Jul, 2011	N/A	No
67544-002-60	90 TABLET in 1 BOTTLE, PLASTIC (67544-002-60)	06 Jul, 2011	N/A	No
67544-002-70	120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70)	06 Jul, 2011	N/A	No
67544-002-72	112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72)	10 Aug, 2021	N/A	No
67544-002-75	150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75)	06 Jul, 2011	N/A	No
67544-002-80	180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80)	06 Jul, 2011	N/A	No
67544-002-85	200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85)	06 Jul, 2011	N/A	No
67544-002-90	240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90)	06 Jul, 2011	N/A	No
67544-002-93	300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)	06 Jul, 2011	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.

Other medicines with the same generic name

Product Elements:

Acetaminophen and codeine phosphate acetaminophen and codeine phosphate acetaminophen acetaminophen codeine phosphate codeine anhydrous crospovidone magnesium stearate cellulose, microcrystalline povidone, unspecified starch, corn stearic acid to off-white 2;m acetaminophen and codeine phosphate acetaminophen and codeine phosphate acetaminophen acetaminophen codeine phosphate codeine anhydrous crospovidone magnesium stearate cellulose, microcrystalline povidone, unspecified starch, corn stearic acid to off-white 3;m acetaminophen and codeine phosphate acetaminophen and codeine phosphate acetaminophen acetaminophen codeine phosphate codeine anhydrous crospovidone magnesium stearate cellulose, microcrystalline povidone, unspecified starch, corn stearic acid to off-white 4;m

Boxed Warning:

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 ( see warnings ). warning: death related to ultra-rapid metabolism of codeine to morphine respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a cyp2d6 polymorphism.

Indications and Usage:

Indications and usage acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.

Warnings:

Warnings 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 rar Read more...

ely, 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. death related to ultra-rapid metabolism of codeine to morphine respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome p450 isoenzyme 2d6 or high morphine concentrations). deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine ( see precautions, nursing mothers ). some individuals may be ultra-rapid metabolizers because of a specific cyp2d6 genotype (gene duplications denoted as *1/*1xn or *1/*2xn). the prevalence of this cyp2d6 phenotype varies widely and has been estimated at 0.5 to 1% in chinese and japanese, 0.5 to 1% in hispanics, 1 to 10% in caucasians, 3% in african americans, and 16 to 28% in north africans, ethiopians, and arabs. data are not available for other ethnic groups. these individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. this rapid conversion results in higher than expected serum morphine levels. even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) ( see overdosage ). children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy ( see contraindications ). when prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose ( see overdosage ). hypersensitivity/anaphylaxis there have been post-marketing reports of hypersensitivity and anaphylaxis associated with the 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 acetaminophen and codeine phosphate tablets usp immediately and seek medical care if they experience these symptoms. do not prescribe acetaminophen and codeine phosphate tablets usp for patients with acetaminophen allergy. head injuries in the presence of head injury or other intracranial lesions, the respiratory-depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. narcotics also produce other cns-depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries. acute abdominal conditions codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. abuse potential codeine is habit-forming and potentially abusable. consequently, the extended use of this product is not recommended.

Dosage and Administration:

Dosage and administration dosage should be adjusted according to severity of pain and response of the patient. the usual adult dosage is: single doses (range) maximum 24-hour dose codeine phosphate 15 mg to 60 mg 360 mg acetaminophen 300 mg to 1000 mg 4000 mg doses may be repeated up to every 4 hours. the prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. this information should be conveyed in the prescription. it should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. equivalently high doses in children would have similar effects.

Contraindications:

Contraindications codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

Adverse Reactions:

Adverse reactions the most frequently observed adverse reactions include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. these effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis. at higher doses, codeine has most of the disadvantages of morphine including respiratory depression.

Overdosage:

Overdosage following an acute overdosage, toxicity may result from codeine or acetaminophen. signs and symptoms toxicity from codeine poisoning includes the opioid triad of pinpoint pupils, depression of respiration, and loss of consciousness. convulsions may occur. in acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. renal tubular necrosis, 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 acetaminophen and codeine 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. for respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist. 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 or more hours 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.

dependence:

Drug abuse and dependence controlled substance acetaminophen and codeine phosphate tablets are classified as a schedule iii controlled substance. abuse and dependence codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Description:

Description acetaminophen and codeine phosphate is supplied in tablet form for oral administration. 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: codeine phosphate, 7,8-didehydro-4,5Î±-epoxy-3-methoxy-17-methylmorphinan-6Î±-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. it has the following structural formula: each acetaminophen and codeine phosphate tablet usp (300 mg/15 mg) contains: acetaminophen usp . . . . . . . . . . . . . 300 mg codeine phosphate usp . . . . . . . . . . . . . 15 mg (warning: may be habit forming) each acetaminophen and codeine phosphate tablet usp (300 mg/30 mg) contains: acetaminophen usp . . . . . . . . . . . . . 300 mg codeine phosphate usp . . . . . . . . . . . . . 30 mg (warning: may be habit forming) each acetaminophen and codeine phosphate tablet usp (300 mg/60 mg) contains: acetaminophen usp . . . . . . . . . . . . . 300 mg codeine phosphate usp . . . . . . . . . . . . . 60 mg (warning: may be habit forming) in addition, each acetaminophen and codeine phosphate tablet usp contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. acetaminophen chemical structure codeine phosphate chemical structure

Clinical Pharmacology:

Clinical pharmacology this product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. pharmacokinetics the behavior of the individual components is described below. codeine â codeine is rapidly absorbed from the gastrointestinal tract. it is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. the plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. the plasma half-life is about 2.9 hours. the elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. the urinary secretion products consist of free and glucuronide c Read more...

onjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). the remainder of the dose is excreted in the feces. at therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours. acetaminophen â 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.

How Supplied:

How supplied repackaged by aphena pharma solutions - tn. see repackaging information for available configurations. each acetaminophen and codeine phosphate tablet usp 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. it is available as a round, white to off-white tablet debossed with â2â on one side and an m on the other side. bottles of 100......................................... ndc 0406-0483-01 each acetaminophen and codeine phosphate tablet usp 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. it is available as a round, white to off-white tablet debossed with â3â on one side and an m on the other side. bottles of 20........................................... ndc 0406-0484-20 bottles of 30........................................... ndc 0406-0484-03 bottles of 50........................................... ndc 0406-0484-50 bottles of 100......................................... ndc 0406-0484-01 bottles of Read more...

1000....................................... ndc 0406-0484-10 unit dose (10 x 10)............................... ndc 0406-0484-62 each acetaminophen and codeine phosphate tablet usp 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. it is available as a round, white to off-white tablet debossed with â4â on one side and an m on the other side. bottles of 100......................................... ndc 0406-0485-01 bottles of 500......................................... ndc 0406-0485-05 store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. dispense in tight, light-resistant container as defined in the usp. mallinckrodt, the âmâ brand mark, the mallinckrodt pharmaceuticals logo and m are trademarks of a mallinckrodt company. Â© 2013 mallinckrodt. mallinckrodt inc. hazelwood, mo 63042 usa rev 10/2013 mallinckrodtâ¢ pharmaceuticals

Package Label Principal Display Panel:

Principal display panel - 15/300mg ndc 67544-001 - codeine phosphate/apap 15/300mg - rx only bottle label 15/300mg

Principal display panel - 30/300mg ndc 67544-002 - codeine phosphate/apap 30/300mg - rx only bottle label 30/300mg

Principal display panel - 60/300mg ndc 67544-003 - codeine phosphate/apap 60/300mg - rx only bottle label 60/300mg

Comments/ Reviews:

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