Hydrocodone Bitartrate And Acetaminophen
Pronunciation: (hye-droe-KOE-done / a-SEET-a-MIN-oh-fen).
- Generic name
- Hydrocodone bitartrate and Acetaminophen
- Brand names
- Lortab, Acetaminophen with Hydrocodone, Anexsia, Hydrocet, Duodin, Norco
- Drug class
- Opioid analgesic combination
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Hydrocodone bitartrate and Acetaminophen is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Hydrocodone bitartrate and Acetaminophen works
Hydrocodone is a semi-synthetic opioid agonist that binds primarily to mu-opioid receptors in the central nervous system, inhibiting ascending pain pathways, altering the perception and response to pain, and producing generalized CNS depression. Acetaminophen is a non-opioid analgesic and antipyretic that is believed to inhibit prostaglandin synthesis in the CNS and block pain impulse generation. (2) (1)
What Hydrocodone bitartrate and Acetaminophen is used for
Moderate to severe pain relief
Moderate to severe pain relief (1)
Post-surgical pain management
Post-surgical pain management (1)
Pain associated with injuries
Pain associated with injuries (1)
Chronic pain management (short-term)
Chronic pain management (short-term) (1)
Before taking Hydrocodone bitartrate and Acetaminophen
Do not take / not appropriate for
- significant respiratory depression, acute or severe bronchial asthma, known hypersensitivity, and paralytic ileus. (Contraindication) (1)
Tell your clinician about
(1)How to take Hydrocodone bitartrate and Acetaminophen
- General Instructions: Take exactly as prescribed by your healthcare provider. Do not take more than the recommended dose or use for longer than directed.. Adult Dosing (CORRECTED — an earlier draft of this record gave two different, mutually inconsistent acetaminophen ranges per tablet; the FDA label for the currently marketed product confirms the figure below): typically one tablet (containing 5-10 mg hydrocodone and up to 325 mg acetaminophen, the current FDA-labeled maximum acetaminophen strength per tablet for marketed combination products) every 4-6 hours as needed for pain. Maximum total daily acetaminophen dose from all sources should not exceed 4,000 mg.. Pediatric Dosing: Not routinely recommended for children. Use only if specifically prescribed by a pediatric specialist, with careful dose calculation based on weight.. Administration: Take with or without food. Swallow tablets whole with a full glass of water. Do not crush or chew extended-release forms.. When To Stop: Seek medical advice promptly if you experience severe side effects, signs of an allergic reaction, or if pain is not controlled; let the clinician you see advise on whether to continue or stop treatment.. Storage: Store at 20-25°C (68-77°F), room temperature, away from moisture and heat, in a tight, light-resistant, child-resistant container. Keep out of reach of children and in a secure location to prevent misuse.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take an extra dose to catch up.
Overdose
An overdose can be fatal, especially in children or adults who are not opioid-tolerant. Symptoms include extreme drowsiness, slow or shallow breathing, pinpoint pupils, cold/clammy skin, and loss of consciousness. Call emergency services or poison control immediately. Acetaminophen overdose can cause severe liver damage—early treatment with acetylcysteine may be lifesaving. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Constipation
Incidence: Reported in the clinician-authored database; frequency not established
Dizziness
Incidence: Reported in the clinician-authored database; frequency not established
Drowsiness
Incidence: Reported in the clinician-authored database; frequency not established
Respiratory depression
Incidence: Reported in the clinician-authored database; frequency not established
Liver damage
Incidence: Reported in the clinician-authored database; frequency not established
Addiction
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING (ADDED — the current FDA label carries a full boxed warning — serious
Symptoms: FDA BOXED WARNING (ADDED — the current FDA label carries a full boxed warning; an earlier draft of this record had these points only as ordinary prose, not flagged as the label's boxed warning): (1) Addiction, Abuse, and Misuse — this medicine exposes patients and other users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death; a prescriber assesses this risk before prescribing and monitors regularly. (2) Life-Threatening Respiratory Depression — risk is greatest when starting treatment or after a dose increase. (3) Accidental Ingestion — accidental ingestion of even one dose, especially by a child, can result in a fatal overdose; keep this medicine secured and out of reach of children and others. (4) Neonatal Opioid Withdrawal Syndrome — prolonged use during pregnancy can result in withdrawal in the newborn, which may be life-threatening if not recognized and treated. (5) Hepatotoxicity — acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often at total daily doses above 4,000 mg or when more than one acetaminophen-containing product is used at the same time. (6) Risks from concomitant use with benzodiazepines or other CNS depressants (including alcohol) — profound sedation, respiratory depression, coma, and death can occur.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include significant respiratory depression, acute or severe bronchial asthma, known hypersensitivity to hydrocodone or acetaminophen (or cross-sensitivity to other opioids), and paralytic ileus. Use caution in patients with hepatic or renal impairment, elderly, those with head injury, hypothyroidism, prostatic hypertrophy, or a history of substance abuse.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Hydrocodone/Acetaminophen can interact with other central nervous system depressants (such as benzodiazepines, alcohol, or other opioids), increasing the risk of respiratory depression, sedation, and overdose. It may also interact with certain antidepressants, anticholinergic drugs, and medications that affect liver enzymes. Always inform your healthcare provider of all medications and supplements you are taking. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
FDA Pregnancy Category C: hydrocodone/acetaminophen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated (see boxed warning) — discuss any use during pregnancy with the clinician managing the pregnancy. (1)
Breastfeeding
Per the FDA NORCO label reviewed for this page, hydrocodone is present in human milk; breastfeeding is not recommended during treatment because of the potential for serious adverse reactions in a breastfed infant, including excess sedation and respiratory depression. If breastfeeding cannot be avoided, the infant should be monitored closely for increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness, and emergency care sought if these occur. (1)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (1)
Renal_impairment
Per the FDA NORCO label reviewed for this page: renal impairment — patients with renal impairment may have higher plasma hydrocodone concentrations because both hydrocodone and the major acetaminophen metabolites are substantially excreted by the kidney; use a low initial dose and monitor closely for adverse effects. Hepatic impairment — the label does not give a specific reduced starting dose, but because acetaminophen carries a well-known risk of severe liver injury and hydrocodone is hepatically metabolized, the total daily acetaminophen dose from all sources should stay well within the 4,000 mg/day ceiling and use should be closely supervised in any degree of existing liver disease. (1)
Hepatic_impairment
Per the FDA NORCO label reviewed for this page: renal impairment — patients with renal impairment may have higher plasma hydrocodone concentrations because both hydrocodone and the major acetaminophen metabolites are substantially excreted by the kidney; use a low initial dose and monitor closely for adverse effects. Hepatic impairment — the label does not give a specific reduced starting dose, but because acetaminophen carries a well-known risk of severe liver injury and hydrocodone is hepatically metabolized, the total daily acetaminophen dose from all sources should stay well within the 4,000 mg/day ceiling and use should be closely supervised in any degree of existing liver disease. (1)
Monitoring
(1)Storage
Store at 20-25°C (68-77°F), USP Controlled Room Temperature. Dispense in a tight, light-resistant container with a child-resistant closure. Keep out of reach of children and in a secure location to prevent misuse.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General (US-marketed combination products, e.g. NORCO)
Indication: Moderate to severe pain relief
Dose summary: CORRECTED — an earlier draft of this record gave two mutually inconsistent acetaminophen ranges (300-1000 mg and 325-650 mg per dose); neither matches the currently marketed product. Per the FDA NORCO label: usual adult dosage is one tablet (hydrocodone 5-10 mg / acetaminophen up to 325 mg, the current FDA-labeled maximum acetaminophen strength per tablet for marketed combination products) every 4-6 hours as needed for pain; total daily acetaminophen from all sources should not exceed 4,000 mg.
Renal context: Per the FDA NORCO label, patients with renal impairment may have higher plasma hydrocodone concentrations, because both hydrocodone and the major acetaminophen metabolites are substantially excreted by the kidney. Use a low initial dose in renal impairment and follow the patient closely for adverse effects; the label does not give a specific numeric dose-reduction percentage. (2) (1)
Frequently asked questions
How quickly does Hydrocodone/Acetaminophen start working?
Pain relief usually begins within 30 to 60 minutes after taking a dose, with peak effects at about 1.3 hours for hydrocodone and 0.5–2 hours for acetaminophen.
Can I take Hydrocodone/Acetaminophen with ibuprofen or aspirin?
Yes, these medications can often be used together for additional pain relief, but always check with your healthcare provider first to avoid potential interactions or side effects.
Is Hydrocodone/Acetaminophen safe during pregnancy?
Use during pregnancy is not recommended unless clearly needed, as prolonged use can cause withdrawal symptoms in the newborn. Discuss risks and benefits with your doctor.
What should I do if I feel very sleepy or confused after taking this medication?
Contact your doctor immediately, as excessive drowsiness or confusion may be a sign of overdose or serious side effects.
Can I drink alcohol while taking Hydrocodone/Acetaminophen?
No. Drinking alcohol increases the risk of severe liver damage and dangerous side effects such as respiratory depression.
How do I safely stop taking Hydrocodone/Acetaminophen?
Do not stop suddenly if you have been taking it regularly for more than a few days. Your doctor will guide you on how to taper the dose gradually to avoid withdrawal symptoms.
What are the signs of Hydrocodone/Acetaminophen addiction?
Signs include craving the medication, taking more than prescribed, inability to control use, and continued use despite harm. If you are concerned, speak with your healthcare provider.
What happens if I take too much Hydrocodone/Acetaminophen?
Taking too much Hydrocodone/Acetaminophen can lead to serious overdose symptoms, including severe drowsiness, slowed breathing, pinpoint pupils, and loss of consciousness. Acetaminophen overdose can cause liver damage. If you suspect an overdose, seek immediate emergency medical attention or call 911. Do not wait for symptoms to worsen.
What is the mechanism of action of Hydrocodone bitartrate and Acetaminophen?
Hydrocodone is a semi-synthetic opioid agonist that binds primarily to mu-opioid receptors in the central nervous system, inhibiting ascending pain pathways, altering the perception and response to pain, and producing generalized CNS depression. Acetaminophen is a non-opioid analgesic and antipyretic that is believed to inhibit prostaglandin synthesis in the CNS and block pain impulse generation. (2) (1)
What is the generic name of Hydrocodone Bitartrate And Acetaminophen?
The generic name is Hydrocodone bitartrate and Acetaminophen. It is sold under brand names including Lortab, Acetaminophen with Hydrocodone, Anexsia, Hydrocet, Duodin, Norco.
What class of drug is Hydrocodone bitartrate and Acetaminophen?
Hydrocodone Bitartrate And Acetaminophen is classed as: Opioid analgesic combination.
References
- NORCO (hydrocodone bitartrate and acetaminophen tablets) — prescribing informationU.S. Food and Drug Administration · United States · dated 2019 · accessed 2026-08-07 · source 1
- Hydrocodone/Acetaminophen Clinician RecordMedGuideGlobal · Global · accessed 2026-08-07 · source 2
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [EYWA PHARMA INC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Hydrocodone Bitartrate and Acetaminophen — FDA approval record (Drugs@FDA ANDA202991)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient Hydrocodone bitartrate and Acetaminophen names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Norco