Oxycodone and Acetaminophen 7.5 mg; 325 mg Tablet, 500-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
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🏭 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 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 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 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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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.
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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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.183 | $91.25 / 500 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2846 | $142.30 / 500 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2090 | $104.50 / 500 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 42806-0115-01 | Epic | 100 tablets | $0.127 | AA | FDA listed | save 30% |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 00406-0522-01 | SpecGx | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 00904-7094-61 | Major | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 10702-0186-01 | KVK-Tech, | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 13107-0045-01 | Aurolife | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 31722-0193-01 | Camber | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 31722-0950-01 | Camber | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 42858-0103-01 | Rhodes | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 47781-0229-01 | Alvogen, | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 50268-0645-15 | AvPAK | 50 tablets | $0.182 | AA | Availability likely | — |
| Endocet 7.5 mg/1; 325 mg 60951-0700-70 | Par | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone Hydrochloride and Acetaminophen 7.5 mg/1; 325 mg 64850-0622-01 | Elite | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mgthis 65162-0207-50 | Amneal | 500 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 68084-0699-01 | American | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 70010-0669-01 | Granules | 100 tablets | $0.182 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71930-0046-12 | Eywa | 100 tablets | $0.182 | AA | Availability likely | — |
| Percocet 7.5 mg/1; 325 mg 63481-0628-70 | SpecGx | 100 tablets | $31.610 | AA | Availability likely | +17225% |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 60760-0898-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Oxycodone Hydrochloride and Acetaminophen 7.5 mg/1; 325 mg 60760-0964-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Endocet 7.5 mg/1; 325 mg 63629-2190-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-0316-00 | Bryant | 84 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1472-00 | Bryant | 84 tablets | — | AA | Discontinued | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1909-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1953-00 | Bryant | 84 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71335-1959-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71335-9675-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 72162-1338-03 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 325 mg/1; 7.5 mg 72189-0256-30 | DIRECT | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 72189-0368-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Oxycodone/APAP 7.5 mg/1; 325 mg 72189-0375-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 72865-0115-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 76420-0322-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 87063-0033-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 43386-0492-01 | Lupin | 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.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 65162-0207-03 | 30 TABLET in 1 BOTTLE (65162-207-03) | — | — | 2013-11-01 | Active |
| 65162-0207-10 | 100 TABLET in 1 BOTTLE (65162-207-10) | $0.1825 / ea | $18.25 | 2013-11-01 | Active |
| 65162-0207-50 You're viewing this | 500 TABLET in 1 BOTTLE (65162-207-50) | $0.1825 / ea | $91.23 | 2013-11-01 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1825 NADAC).
This pack accounts for about 2.0% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 65162-0207-50?
What is the difference between NDC 65162-0207-50 and NDC 65162-0207-03?
What NDC number is used to bill for this package of Oxycodone and Acetaminophen 7.5 mg; 325 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ACETAMINOPHEN TABLETS Addiction, Abuse, and Misuse Because the use of 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 and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone and Acetaminophen Tablets, especially during initiation or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of Oxycodone and Acetaminophen Tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Oxycodone and Acetaminophen Tablets, especially by children, can result in a fatal overdose of Oxycodone [see WARNINGS ]. 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.
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 [see WARNINGS ; PRECAUTIONS ; Drug Interactions ]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ]. Cytochrome P450 3A4 Interaction The concomitant use of Oxycodone and Acetaminophen 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 concentrations. 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 4,000 mg per day, and often involve more than one acetaminophen-containing product.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets are 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Oxycodone and Acetaminophen Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxycodone and Acetaminophen Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone and Acetaminophen Tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see WARNINGS ].
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
The presence of risk factors for overdose should not prevent the management of pain in any patient (see WARNINGS; Addiction, Abuse, and Misuse ; Life-Threatening Respiratory Depression ; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ). Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Initial Dosage Use of Oxycodone and Acetaminophen Tablets as the First Opioid Analgesic Initiate treatment with Oxycodone and Acetaminophen Tablets using Oxycodone and Acetaminophen Tablets 2.5 mg/325 mg tablets in a dosing range of 1 to 2 tablets every 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone and Acetaminophen Tablets.
The total daily dose of acetaminophen should not exceed 4 grams. Strength Usual Adult Dosage Maximal Daily Dose Oxycodone and Acetaminophen Tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets Conversion from Oxycodone 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 may lead to increased risk of excessive sedation and respiratory depression.
Titration and Maintenance of Therapy Individually titrate Oxycodone and…
⛔ Contraindications ▾
CONTRAINDICATIONS Oxycodone and Acetaminophen Tablets are 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. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use (see ADVERSE REACTIONS ).
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone and Acetaminophen Tablets, and reassess 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 frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see WARNINGS , DOSAGE AND ADMINISTRATION ]. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use.
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 careful storage of the drug during the course of treatment and 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.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient’s clinical status [see OVERDOSAGE ].
Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Oxycodone and Acetaminophen Tablets, the risk is greatest during the initiation of therapy or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Oxycodone and Acetaminophen Tablets are essential [see DOSAGE AND ADMINISTRATION ].
Overestimating the Oxycodone and Acetaminophen Tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Accidental ingestion of Oxycodone and Acetaminophen Tablets, especially by children, can result in respiratory depression and death due to an overdose of Oxycodone and Acetaminophen Tablets. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdo…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Postmarketing Experience 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 use of opioids for an extended period of time [see CLINICAL PHARMACOLOGY ] .
Hyperalgesia and Allodynia:…
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Clinical Presentation Oxycodone 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, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations (see CLINICAL PHARMACOLOGY ).
Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.. 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 measures. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene.
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 re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the overdose reversal agent 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 reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should begin with care and by titration with smaller than usual doses of the reversal agent. 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, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED). 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.
Use of opioids for an extended period of time 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 opioid agonists. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg are supplied as white to off-white, capsule-shaped, biconvex tablets, debossed “IP207” on obverse and plain on reverse. They are available as follows: Bottles of 30: NDC 65162-207-03 Bottles of 100: NDC 65162-207-10 Bottles of 500: NDC 65162-207-50 Storage 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 /Caregivers ]. Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev.
10-2025-15
📋 Description ▾
DESCRIPTION Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains: Oxycodone Hydrochloride USP……………. 7.5 mg* (*7.5 mg Oxycodone Hydrochloride, USP is equivalent to 6.7228 mg Oxycodone) Acetaminophen USP………………………325 mg Inactive Ingredients The tablets contain colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.
Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 •HCl and the molecular weight 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone and Acetaminophen Tablets, USP, contain acetaminophen, USP, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
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: 567187af-figure-01 567187af-figure-02
💬 Patient Medication Information ▾
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.
TAsk your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking Oxycodone and Acetaminophen Tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), 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: Noticing your pain getting worse. If your pain gets worse after you take Oxycodone and Acetaminophen Tablets, do not take more of Oxycodone and Acetaminophen Tablets without first talking to your healthcare provider.
Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Oxycodone and Acetaminophen Tablets. Pregnant or planning to become pregnant. Use of Oxycodone and Acetaminophen Tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Breastfeeding. Oxycodone and Acetaminophen passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness.
Seek immediate medical care if you notice these signs. 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. For acute (short-term) pain, you may only need to take Oxycodone and Acetaminop…