Oxycodone and Acetaminophen 10 mg; 325 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2090 | $6.27 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 42806-0116-01 | Epic | 100 tablets | $0.199 | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 43386-0493-01 | Lupin | 100 tablets | $0.201 | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 00406-0523-01 | SpecGx | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 00904-7095-61 | Major | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 10702-0187-01 | KVK-Tech, | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 13107-0046-01 | Aurolife | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 31722-0194-01 | Camber | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 31722-0951-01 | Camber | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 42858-0104-01 | Rhodes | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 47781-0230-01 | Alvogen, | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 325 mg/1; 10 mg 50268-0646-15 | AvPAK | 50 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 53746-0204-01 | Amneal | 100 tablets | $0.236 | AA | Availability likely | — |
| Endocet 10 mg/1; 325 mg 60951-0712-70 | Par | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone Hydrochloride and Acetaminophen 10 mg/1; 325 mg 64850-0623-01 | Elite | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 68084-0710-01 | American | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 70010-0670-01 | Granules | 100 tablets | $0.236 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 71930-0047-12 | Eywa | 100 tablets | $0.236 | AA | Availability likely | — |
| Percocet 10 mg/1; 325 mg 63481-0629-70 | SpecGx | 100 tablets | $41.444 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 60760-0899-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Oxycodone Hydrochloride and Acetaminophen 10 mg/1; 325 mg 60760-0965-60 | St. | 60 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 61919-0871-30 | Direct_Rx | 30 tablets | — | AA | Discontinued | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 63187-0363-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 63187-0721-15 | Proficient | 15 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 63187-0823-15 | Proficient | 15 tablets | — | AA | FDA listed | — |
| Endocet 325 mg/1; 10 mg 63629-2187-01 | Bryant | 100 tablets | — | AA | Discontinued | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 63629-8834-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 63629-8876-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 63629-9501-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 71205-0347-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mgthis 71205-0486-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 71335-0146-00 | Bryant | 112 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 71335-1036-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 71335-1420-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 71335-2049-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 71335-2106-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Endocet 10 mg/1; 325 mg 71335-2182-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 72162-1339-03 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Endocet 10 mg/1; 325 mg 72162-1728-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 72189-0255-30 | DIRECT | 30 tablets | — | AA | FDA listed | — |
| Percocet 325 mg/1; 10 mg 72189-0397-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 72865-0116-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 10 mg/1; 325 mg 76420-0209-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 76420-0323-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 10 mg/1; 325 mg 87063-0034-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71205-0486-30 You're viewing this | 30 TABLET in 1 BOTTLE (71205-486-30) | 2020-10-14 | Active |
| 71205-0486-60 | 60 TABLET in 1 BOTTLE (71205-486-60) | 2020-10-14 | Active |
| 71205-0486-90 | 90 TABLET in 1 BOTTLE (71205-486-90) | 2020-10-14 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71205-0486-30?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS) Oxycodone and Acetaminophen Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Oxycodone and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see WARNINGS]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone and Acetaminophen Tablets. Monitor for respiratory depression, especially during initiation of Oxycodone and Acetaminophen Tablets or following a dose increase [see WARNINGS]. Accidental Ingestion Accidental ingestion of Oxycodone and Acetaminophen Tablets, especially by children, can result in a fatal overdose of Oxycodone and Acetaminophen Tablets [see WARNINGS].
Neonatal Opioid Withdrawal Syndrome Prolonged use of Oxycodone and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS]. Cytochrome P450 3A4 Interaction The concomitant use of Oxycodone Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone and Acetaminophen Tablets and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions]. 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 mg per day, and often involve more than one acetaminophen-containing product. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; Drug Interactions]. • Reserve concomitant prescribing of Oxycodone and Acetaminophen Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. •…
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Oxycodone and Acetaminophen Tablets and adjust the dosage accordingly [see WARNINGS].
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with Oxycodone and Acetaminophen Tablets [see WARNINGS, Life-Threatening Respiratory Depression; PRECAUTIONS, Information for Patients/Caregivers]. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing regulations (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patients risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see WARNINGS, Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants]. Consider prescribing naloxone when the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose .
Initial Dosage Initiating Treatment with Oxycodone and Acetaminophen Tablets The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. Strength Usual Adult Dosage Maximum Daily Dose Oxycodone and acetaminophen tablets 5 mg/325 mg 1 tablet every 6 hours as needed for pain 12 Tablets Oxycodone and acetaminophen tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets Oxycodone and acetaminophen tablets 10 mg/325 mg 1 tablet every 6 hours as needed for pain 6 Tablets Conversion from Oxycodone Hydrochloride and Acetaminophen to Extended-Release Oxycodone The relative bioavailability of Oxycodone and Acetaminophen Tablets compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Titration and Maintenance of Therapy Individually titrate Oxycodone and Acetaminophen Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Oxycodone and Acetaminophen Tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone and Acetaminophen Tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Safe Reduction or Discontinuation of Oxycodone and Acetaminophen Tablets Do not abrup…
⛔ Contraindications ▾
CONTRAINDICATIONS Oxycodone and Acetaminophen Tablets is contraindicated in patients with: • Significant respiratory depression [see WARNINGS] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] • Hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see WARNINGS, ADVERSE REACTIONS]
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse Oxycodone and Acetaminophen Tablets contain oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone and Acetaminophen Tablets exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxycodone and Acetaminophen Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone and Acetaminophen Tablets, and monitor all patients receiving Oxycodone and Acetaminophen Tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Oxycodone and Acetaminophen Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Oxycodone and Acetaminophen Tablets along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS, Life-Threatening Respiratory Depression; DOSAGE AND ADMINISTRATION, Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose].
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Oxycodone and Acetaminophen Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PRECAUTIONS; Information for Patients/Caregivers].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG. • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com .
The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Oxycodone and Acetaminophen Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE].
The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.
Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use.
In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur. Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen are listed by organ system and in decreasing order of severity and/or frequency as follows: Body as a Whole: Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose Cardiovascular: Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias Central and Peripheral Nervous System: Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal: Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastrointestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus Hepatic: Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder Hearing and Vestibular: Hearing loss, tinnitus Hematologic: Thrombocytopenia Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction Metabolic and Nutritional: Hypoglycemia, hyperglycemia, acidosis, alkalosis Musculoskeletal: Myalgia, rhabdomyolysis Ocular: Miosis, visual disturbances, red eye Psychiatric: Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide Respiratory System: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema Skin and Appendages: Erythema, urticaria, rash, flushing Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention • Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. • Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. • Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Oxycodone and Acetaminophen Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology].
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Clinical Presentation Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen Dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. 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 of Overdose Oxycodone In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or arrhythmias will require advanced life-support techniques. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.
Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone and Acetaminophen Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.
The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist. Acetaminophen 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Pharmacodynamics Effects on the Central Nervous System Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.
Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.
Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the Gastrointestinal Tract and Other Smooth Muscle Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased.
Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Oxycodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope.
Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS]. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see ADVERSE REACTIONS]. Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system.
The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive. Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.
The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, a…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 10 mg/325 mg White to off-white color capsule shaped tablets debossed with ‘ T 194’ on one side and plain on other side. Bottles of 30 NDC 71205-486-30 Bottles of 60 NDC 71205-486-60 Bottles of 90 NDC 71205-486-90 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients]. Manufactured by: Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev: 07/20
📋 Description ▾
DESCRIPTION Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains: Oxycodone hydrochloride, USP 2.5 mg * ( * 2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone hydrochloride, USP 5 mg * ( * 5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone hydrochloride, USP 7.5 mg * ( * 7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone hydrochloride, USP 10 mg * ( * 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg Inactive Ingredients The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder.
The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula: Oxycodone HCl-Struct Acetaminophen-Struct
💬 Medication Guide ▾
Medication Guide Medication Guide Oxycodone (ox" i koe' done ) and Acetaminophen (a seet" a min' oh fen) Tablets, CII Oxycodone and Acetaminophen Tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Oxycodone and Acetaminophen Tablets: • Get emergency help or call 911 right away if you take too much Oxycodone and Acetaminophen Tablets (overdose). When you first start taking Oxycodone and Acetaminophen Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking Oxycodone and Acetaminophen Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your Oxycodone and Acetaminophen Tablets. They could die from taking it. Selling or giving away Oxycodone and Acetaminophen Tablets is against the law. • Store Oxycodone and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take Oxycodone and Acetaminophen Tablets if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines • known hypersensitivity to oxycodone, acetaminophen, or any ingredient in Oxycodone and Acetaminophen Tablets Before taking Oxycodone and Acetaminophen Tablets, tell your healthcare provider if you have a history of: • Head injury, seizures • Liver, kidney, thyroid problems • Problems urinating • Pancreas or gallbladder problems • Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you are: • Pregnant or planning to become pregnant . Prolonged use of Oxycodone and Acetaminophen Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • Breastfeeding . Oxycodone and Acetaminophen Tablets passes into breast milk and may harm your baby. • living in a household where there are small children or someone who has abused street or prescription drugs. • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
Taking Oxycodone and Acetaminophen Tablets with certain other medicines can cause serious side effects that could lead to death. When taking Oxycodone and Acetaminophen Tablets: • Do not change your dose. Take Oxycodone and Acetaminophen Tablets exactly as prescribed by your healthcare provider.
Use the lowest dose possible for the shortest time needed. • Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time. • Call your healthcare provider if the dose you are taking does not control your pain. • If you have been taking Oxycodone and Acetaminophen Tablets regularly, do not stop taking Oxycodone and Acetaminophen Tablets without talking to your healthcare provider. • Dispose of expired, unwanted, or unused Oxycodone and Acetaminophen Tablets by promptly flushing down the toilet, if a drug take-back option is not readily available.
Visit www.fda.gov/drugdisposal for additional information on disposa…