Hydrocodone bitartrate and ibuprofen

What Hydrocodone bitartrate and ibuprofen is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. …

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS. Read it on the full label →

2 of 2 FDA labels for this medicine have a boxed warning.

Hydrocodone bitartrate and ibuprofen boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS Addiction, Abuse, and Misuse Because the use of hydrocodone bitartrate and ibuprofen 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).

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Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and ibuprofen, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and ibuprofen are essential (see WARNINGS). Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and ibuprofen, especially by children, can result in a fatal overdose of hydrocodone (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 hydrocodone bitartrate and ibuprofen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate (see WARNINGS). 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 hydrocodone bitartrate and ibuprofen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients taking hydrocodone bitartrate and ibuprofen and any CYP3A4 inhibitor or upon discontinuation of a CYP3A4 inducer for signs and symptoms of respiratory depression and sedation (see WARNINGS: Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers, PRECAUTIONS: Drug Interactions). Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS: Cardiovascular Thrombotic Events).

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. This is part of the section. Read the full label on DailyMed →

Hydrocodone bitartrate and ibuprofen side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following adverse reactions are described below and elsewhere in the labeling including the WARNINGS section.

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Addiction, Abuse, and Misuse Life-Threatening Respiratory Depression Neonatal Opioid Withdrawal Syndrome Interactions with Cytochrome P450 3A4 Inhibitors and Inducers Interactions with Benzodiazepines or Other CNS Depressants Adrenal Insufficiency Severe Hypotension Seizures Withdrawal Cardiovascular Thrombotic Events Gastrointestinal Bleeding, Ulceration, and Perforation Hepatotoxicity Hypertension Heart Failure and Edema Renal Toxicity and Hyperkalemia Anaphylactic Reactions Exacerbation of Asthma Related to Aspirin Sensitivity Serious Skin Reactions Premature Closure of Fetal Ductus Arteriosus Hematologic Toxicity Aseptic Meningitis Opioid-Induced Hyperalgesia and Allodynia (see WARNINGS) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hydrocodone bitartrate and ibuprofen was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of hydrocodone bitartrate and ibuprofen an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg. The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of hydrocodone bitartrate and ibuprofen, without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows: name of adverse event = less than 3% adverse events marked with an asterisk * = 3% to 9% adverse event rates over 9% are in parentheses. Body as a Whole Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain. Cardiovascular Palpitations; Vasodilation. Central Nervous System Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking abnormalities. Digestive Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*. Metabolic and Nutritional Disorders Edema*. Respiratory Dyspnea; Hiccups; Pharyngitis; Rhinitis. Skin and Appendages Pruritus*; Sweating*. Special Senses Tinnitus. Urogenital Urinary frequency.

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. This is part of the section. Read the full label on DailyMed →

Hydrocodone bitartrate and ibuprofen dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Important Dosage and Administration Instructions Hydrocodone bitartrate and ibuprofen 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).

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Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of hydrocodone bitartrate and ibuprofen 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 hydrocodone bitartrate and ibuprofen 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.

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. This is part of the section. Read the full label on DailyMed →

When Hydrocodone bitartrate and ibuprofen should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with: Significant respiratory depression (see WARNINGS: Life-Threatening Respiratory Depression). Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS: Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients).

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Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS: Risks of Use in Patients with Gastrointestinal Conditions). Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product (see WARNINGS: Anaphylactic Reactions, Serious Skin Reactions). Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic Reactions, Exacerbation of Asthma Related to Aspirin Sensitivity). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS: Cardiovascular Thrombotic Events).

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. Read the full label on DailyMed →

Hydrocodone bitartrate and ibuprofen overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Following an acute overdosage, toxicity may result from hydrocodone and/or ibuprofen.

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Clinical Presentation Hydrocodone Component Acute overdose with hydrocodone bitartrate and ibuprofen tablets 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. Ibuprofen Component Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare (see WARNINGS: Hypertension, Renal Toxicity and Hyperkalemia). Treatment of Overdose In case of overdose, priorities are the re-establishment 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 opioid 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 hydrocodone, 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 be begun with care and by titration with smaller than usual doses of the reversal agent. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.

— FDA label: Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025. This is part of the section. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• IbuprofenIbu, Caldolor · 318 products
• Hydrocodone bitartrate and acetaminophenNorco · 208 products
• Ibuprofen and famotidine21 products
• Hydrocodone bitartrateHysingla ER · 19 products
• Acetaminophen and ibuprofenCombogesic, Combogesic IV · 5 products
• Hydrocodone polistirex and chlorpheniramine polistirexHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release · 3 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Amneal Pharmaceuticals of New York LLC4 products
• Aurolife Pharma, LLC1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (2)

• ANDA076642Amneal Pharms Ny · March 18, 2004
• ANDA204575Aurolife Pharma LLC · June 2, 2016

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Amneal Pharmaceuticals of New York LLCMaker or distributor
• Aurolife Pharma, LLCMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Hydrocodone Bitartrate and Ibuprofen, Amneal Pharmaceuticals of New York LLC, effective November 21, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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