Oxycodone and Acetaminophen 10 mg; 325 mg Tablet, 12-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 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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 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.
6 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 | $2.51 / 12 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 mgthis 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 mg 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.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63187-0363-12 You're viewing this | 12 TABLET in 1 BOTTLE (63187-363-12) | 2016-11-01 | Active |
| 63187-0363-15 | 15 TABLET in 1 BOTTLE (63187-363-15) | 2016-08-01 | Active |
| 63187-0363-20 | 20 TABLET in 1 BOTTLE (63187-363-20) | 2016-08-01 | Active |
| 63187-0363-30 | 30 TABLET in 1 BOTTLE (63187-363-30) | 2016-08-01 | Active |
| 63187-0363-60 | 60 TABLET in 1 BOTTLE (63187-363-60) | 2016-08-01 | Active |
You're viewing the smallest of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 63187-0363-12?
What is the difference between NDC 63187-0363-12 and NDC 63187-0363-15?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule.
Oxycodone and Acetaminophen Tablets are given orally. Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg 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 Maximal Daily Dose Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg 12 Tablets Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg 8 Tablets Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg 6 Tablets Cessation of Therapy In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
⛔ Contraindications ▾
CONTRAINDICATIONS Oxycodone and Acetaminophen Tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.
⚠️ Warnings ▾
WARNINGS Misuse, Abuse and Diversion of Opioids Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing Oxycodone and Acetaminophen Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Administration of Oxycodone and Acetaminophen Tablets should be closely monitored for the following potentially serious adverse reactions and complications: Respiratory Depression Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in Oxycodone and Acetaminophen Tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration.
Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE ). Head Injury and Increased Intracranial Pressure The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.
Hypotensive Effect Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.
Hepatoxicity 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 Re…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Serious adverse reactions that may be associated with Oxycodone and Acetaminophen Tablets 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 Tablets 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, gastro-intestinal 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
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Tablets. It is also not known whether Oxycodone and Acetaminophen Tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and Acetaminophen Tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Nonteratogenic Effects Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. Opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate may suffer severe withdrawal symptoms.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Special precaution should be given when determining the dosing amount and frequency of Oxycodone and Acetaminophen Tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Signs and Symptoms Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension.
In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death 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 oxycodone and acetaminophen 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.
Oxycodone Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including oxycodone. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
An opioid antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. 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 Central Nervous System Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably μ and κ) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins.
Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined.
The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers. Gastrointestinal Tract And Other Smooth Muscle Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum. In the small intestine, digestion of food is delayed by decreases in propulsive contractions.
Other opioid effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased ureteral and bladder sphincter tone, and a reduction in uterine tone. Cardiovascular System Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such as pruritus, flushing, red eyes, and sweating. Pharmacokinetics Absorption and Distribution The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%.
Oxycodone has been shown to be 45% bound to human plasma proteins in vitro . The volume of distribution after intravenous administration is 211.9 ±186.6 L. Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration.
With overdosage, absorption is complete in 4 hours. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.
Metabolism and Elimination A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism. Oxymorphone, is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6.
Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone. Approximately 8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration. Following a single, oral dose of oxycodone, the mean ± SD elimination half-life is 3.51 ± 1.43 hours.
Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 80-85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. After hepatic conjugation, 90 to 100% of the drug is recovered in the urine within the first day.
About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified by conjugation with glutathione, present in a fixed amount. It is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased.
At high doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen by alternate pathways.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Oxycodone and Acetaminophen Tablets are supplied as follows: 5 mg/325 mg Blue, round tablet, debossed with "ALV" and "196", separated by a bisect, on one side, and plain on the other side. Bottles of 12: NDC 63187-719-12 Bottles of 15: NDC 63187-719-15 Bottles of 20: NDC 63187-719-20 Bottles of 30: NDC 63187-719-30 Bottles of 60: NDC 63187-719-60 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “ ” on the other side. Bottles of 12: NDC 63187-363-12 Bottles of 15: NDC 63187-363-15 Bottles of 20: NDC 63187-363-20 Bottles of 30: NDC 63187-363-30 Bottles of 60: NDC 63187-363-60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). d77de3aeb01482e6
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
📋 Description ▾
DESCRIPTION Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 5 mg* Acetaminophen, USP 325 mg *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. All strengths of Oxycodone and Acetaminophen Tablets also contain the following inactive ingredients: Pregelatinized cornstarch, povidone, lactose monohydrate, crospovidone, and stearic acid. In addition, the 5 mg/325 mg strength contains FD&C Blue No.
1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake.
The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. Oxycodone, 14-hydroxydihydrocodeinone, is 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: Acetaminophen, 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: c78d66e2-figure-01 c78d66e2-figure-02
💬 Information for Patients ▾
Information for Patients/Caregivers The following information should be provided to patients receiving Oxycodone and Acetaminophen Tablets by their physician, nurse, pharmacist, or caregiver: 1. Do not take Oxycodone and Acetaminophen Tablets if you are allergic to any of its ingredients. 2.
If you develop signs of allergy such as a rash or difficulty breathing stop taking Oxycodone and Acetaminophen Tablets and contact your healthcare provider immediately. 3. Do not take more than 4000 milligrams of acetaminophen per day.
Call your doctor if you took more than the recommended dose. 4. Patients should be aware that Oxycodone and Acetaminophen Tablets contain oxycodone, which is a morphine-like substance.
5. Patients should be instructed to keep Oxycodone and Acetaminophen Tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
6. When Oxycodone and Acetaminophen Tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet. 7.
Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician. 8.
Patients should be advised that Oxycodone and Acetaminophen Tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery). 9. Patients should not combine Oxycodone and Acetaminophen Tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician.
When co-administered with another CNS depressant, Oxycodone and Acetaminophen Tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death. 10. The safe use of Oxycodone and Acetaminophen Tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking Oxycodone and Acetaminophen Tablets.
11. Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue Oxycodone and Acetaminophen Tablets because of the potential for serious adverse reactions to nursing infants. 12.
Patients who are treated with Oxycodone and Acetaminophen Tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication. 13.
Patients should be advised that Oxycodone and Acetaminophen Tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.