Medicine guide
Oxycodone and Acetaminophen
10 mg + 325 mg · Tablet
- Prescription only
- Controlled substance · CII
- Opioid Agonist
- Active substance
- Oxycodone and Acetaminophen
- Made by
- Proficient Rx LP
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2019-11-01
What it is
Opioid Agonist
Used for
- Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
Serious warning
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
All warnings ↓Good to know
- Prescription only
- Controlled substance (schedule II) — extra rules apply to prescribing and refills
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
From the official label · 2019-11-01 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Half-life1.43 h
Mostly cleared after≈ 7.2 hfive half-lives — our arithmetic
How the body breaks it down
The metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6.
How it leaves the body
Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone.
With food
In the small intestine, digestion of food is delayed by decreases in propulsive contractions.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2019-11-01
Serious warning
The strongest warning the FDA requires. It is printed in a box at the top of the label.
- 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.
Quoted from the official label, section “Boxed Warning”.
Do not take it if
- 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.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other 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.
- The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
- The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
- Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.
- Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
- Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
- Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
- Hypersensitivity / Anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
- Clinical signs including swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.
- There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.
- Instruct patients to discontinue Oxycodone and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms.
- Do not prescribe Oxycodone and Acetaminophen Tablets for patients with acetaminophen allergy.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Side effects
- 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
Quoted from the official label, section “Adverse Reactions”.
How to store it
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).
Quoted from the official label, section “Storage and Handling”.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Proficient Rx LP |
|---|---|
| Active substance | Oxycodone and Acetaminophen |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 10 mg + 325 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 12 TABLET in 1 BOTTLE · 15 TABLET in 1 BOTTLE · 20 TABLET in 1 BOTTLE |
| NDC | 63187-363 |
| NDC | 63187-721 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
75 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet74 products
2.5 mg + 325 mg6
- 2.5 mg + 300 mg
- 5 mg + 300 mg
7.5 mg + 325 mg19
- 7.5 mg + 300 mg
10 mg + 325 mg20
- 10 mg + 300 mg
- 325 mg + 10 mg
- 325 mg + 2.5 mg
- 325 mg + 7.5 mg
- Solution1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
Endocet5 mg + 325 mgPrescription only Par Health USA, LLC · Oxycodone and AcetaminophenEndocet7.5 mg + 325 mgPrescription only Par Health USA, LLC · Oxycodone and AcetaminophenEndocet2.5 mg + 325 mgPrescription only Par Health USA, LLC · Oxycodone and AcetaminophenEndocet10 mg + 325 mgPrescription only Par Health USA, LLC · Oxycodone and AcetaminophenEndocet7.5 mg + 325 mgPrescription only Bryant Ranch Prepack · Oxycodone and AcetaminophenEndocet5 mg + 325 mgPrescription only Redpharm Drug · Oxycodone and Acetaminophen