Prescription medicine
Aspirin, butalbital, caffeine and codeine
Aspirin, butalbital, caffeine and codeine is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $1.00 per ascomp with codeine capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the aspirin, butalbital, caffeine and codeine FDA label on DailyMed (effective May 27, 2026, Bryant Ranch Prepack); the NDA 19429 record on Drugs@FDA; every aspirin, butalbital, caffeine and codeine label on DailyMed.
Highlights of the record
FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ASCOMP WITH CODEINE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF.
ASCOMP with Codeine See full prescribing information for complete boxed warning. ASCOMP with Codeine exposes users to the risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ( 5.2 ) Accidental ingestion of ASCOMP with Codeine, especially by children, can result in fatal overdose. ( 5.2 ) Concomitant use of opioids or a barbiturate with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. ( 5.3 , 5.9 , 7 ) Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. […]
Used for
From the label: indications and usageASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.
Forms and strengths
- 50 mg / 325 mg / 40 mg / 30 mg
Capsule.
On the market
- Earliest approval on file
- October 26, 1990 Fiorinal W/Codeine, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first August 31, 1995; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.00 per capsule Ascomp with codeine capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 53 through July 30, 2026
What is aspirin, butalbital, caffeine and codeine used for?
From the label: indications and usageASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. ASCOMP with Codeine is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. […]
Conditions named in the indications of aspirin, butalbital, caffeine and codeine's FDA labels, with every medicine labeled for each:
From other aspirin, butalbital, caffeine and codeine labelsPain: … e, and Codeine Phosphate Capsules, USP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of […]
FDA pharmacologic class: Barbiturate, Central Nervous System Stimulant, Methylxanthine, Nonsteroidal Anti-inflammatory Drug, Opioid Agonist and Platelet Aggregation Inhibitor.
Source: FDA drug label (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE), ANDA075231 (Lgm Pharma), as published by Bryant Ranch Prepack, effective May 27, 2026 (SPL set 95a33c9b-79a6-47c7-8433-fc217950b88f), via openFDA; the full label on DailyMed
Is there a generic for aspirin, butalbital, caffeine and codeine?
The FDA approved the first generic aspirin, butalbital, caffeine and codeine on August 31, 1995. 5 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists aspirin, butalbital, caffeine and codeine from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1990 earliest approval on file
- 1995 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aspirin, butalbital, caffeine and codeine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.00 per Ascomp with codeine capsule, up 6% from $0.951 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ascomp with codeine capsule (generic)
$1.49
$0.766
January 2024October 2026
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Asa-butalb-caff-cod #3 capsule | Generic | $1.00 per capsule | $30.12 | +6% |
| Ascomp with codeine capsule | Generic | $1.00 per capsule | $30.12 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the aspirin, butalbital, caffeine and codeine label say about other medicines?
The aspirin, butalbital, caffeine and codeine label names 57 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Clinical Impact: Aspirin inhibits the uricosuric effects of uricosuric agents. … evaluate patient for any adverse effects from the carbonic anhydrase inhibitor. Acetazolamide, methazolamide Methotrexate |
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of ASCOMP with Codeine with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine plasma concentration … |
| Amphotericin b | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … agents. Frequently evaluate the renal function of patients. Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) … |
| Apixaban | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Bacitracin | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … the renal function of patients. Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) Inhibitors |
| Buprenorphine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Bupropion | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … of respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and other Central Nervous System (CNS) Depressants |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of ASCOMP with Codeine and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine, Muscle Relaxants |
| Captopril | drug interactions | Angiotensin Converting Enzyme (ACE) Inhibitors Clinical Impact: The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of aspirin due to its indirect effect on the renin-angiotensin conversion pathway. Intervention: Use caution if using concomitantly. Evaluate the blood pressure and renal function of patients. Examples: Ramipril, captopril |
| Carbamazepine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of ASCOMP with Codeine and evaluate patients at frequent … |
| Cisplatin | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … function of patients. Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) Inhibitors |
| Clopidogrel | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … patients. Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) Inhibitors |
Every other medicine the aspirin, butalbital, caffeine and codeine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Diclofenac | drug interactions | Clinical Impact: Concurrent use with aspirin may increase the risk of bleeding or lead to decreased renal function. Aspirin may enhance serious side effects and toxicity of ketorolac by displacing it from its plasma protein binding sites and/or reducing its … Intervention: Avoid concomitant use. Ketorolac, ibuprofen, naproxen, diclofenac Corticosteroids |
| Divalproex | drug interactions | Clinical Impact: Aspirin can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels. Intervention: Use caution if using concomitantly. Phenytoin, valproic acid Nonsteroidal Anti-inflammatory Drugs (NSAIDs) |
| Enoxaparin | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Erythromycin | drug interactions | Clinical Impact: The concomitant use of ASCOMP with Codeine and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the ASCOMP with Codeine dosage as … |
| Fluoxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … and symptoms of respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and other Central Nervous System (CNS) Depressants |
| Foscarnet | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … Aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) Inhibitors |
| Glimepiride | drug interactions | Clinical Impact: Aspirin may increase the serum glucose-lowering action of insulin and sulfonylureas leading to hypoglycemia. Intervention: Patients should be advised to consult a physician if any signs or symptoms of hypoglycemia occur. Insulin, glimepiride, glipizide Anticonvulsants |
| Glipizide | drug interactions | Clinical Impact: Aspirin may increase the serum glucose-lowering action of insulin and sulfonylureas leading to hypoglycemia. Intervention: Patients should be advised to consult a physician if any signs or symptoms of hypoglycemia occur. Insulin, glimepiride, glipizide Anticonvulsants |
| Heparin | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Hydrocodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory … |
| Ibuprofen | drug interactions | Clinical Impact: Concurrent use with aspirin may increase the risk of bleeding or lead to decreased renal function. Aspirin may enhance serious side effects and toxicity of ketorolac by displacing it from its plasma protein binding sites and/or reducing its … Intervention: Avoid concomitant use. Ketorolac, ibuprofen, naproxen, diclofenac Corticosteroids |
| Ketoconazole | drug interactions | Clinical Impact: The concomitant use of ASCOMP with Codeine and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the ASCOMP with Codeine dosage as … |
| Ketorolac | drug interactions | Clinical Impact: Concurrent use with aspirin may increase the risk of bleeding or lead to decreased renal function. Aspirin may enhance serious side effects and toxicity of ketorolac by displacing it from its plasma protein binding sites and/or reducing its … Intervention: Avoid concomitant use. Ketorolac, ibuprofen, naproxen, diclofenac Corticosteroids |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methazolamide | drug interactions | Clinical Impact: Aspirin inhibits the uricosuric effects of uricosuric agents. … any adverse effects from the carbonic anhydrase inhibitor. Acetazolamide, methazolamide Methotrexate |
| Methotrexate | drug interactions | Clinical Impact: Aspirin inhibits the uricosuric effects of uricosuric agents. … effects from the carbonic anhydrase inhibitor. Acetazolamide, methazolamide Methotrexate |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metoprolol | drug interactions | Beta Blockers Clinical Impact: The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow, and salt and fluid retention. Intervention: Use caution if using concomitantly. Evaluate the blood pressure and renal function of patients. Examples: Metoprolol, propranolol |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
| Morphine | boxed warning | … consideration of the effects on codeine, and the active metabolite, morphine. ( 5.7 , 5.9 , 7 ) Addiction, Abuse, and Misuse Because the use of ASCOMP with Codeine exposes patients and other users to … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of ASCOMP with Codeine and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine, Muscle Relaxants |
| Naloxone | drug interactions | Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. … (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers … |
| Naproxen | drug interactions | Clinical Impact: Concurrent use with aspirin may increase the risk of bleeding or lead to decreased renal function. Aspirin may enhance serious side effects and toxicity of ketorolac by displacing it from its plasma protein binding sites and/or reducing its … Intervention: Avoid concomitant use. Ketorolac, ibuprofen, naproxen, diclofenac Corticosteroids |
| Oxycodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and … |
| Oxymorphone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Paroxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … intervals for signs and symptoms of respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and other Central Nervous System (CNS) Depressants |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of ASCOMP with Codeine and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin |
| Prasugrel | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Probenecid | drug interactions | Clinical Impact: Aspirin inhibits the uricosuric effects of uricosuric agents. Intervention: Avoid concomitant use. Probenecid Carbonic Anhydrase Inhibitors Clinical Impact: Concurrent use with aspirin can lead to high serum concentrations of the carbonic anhydrase inhibitor and cause toxicity due … |
| Propranolol | drug interactions | Beta Blockers Clinical Impact: The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow, and salt and fluid retention. Intervention: Use caution if using concomitantly. Evaluate the blood pressure and renal function of patients. Examples: Metoprolol, propranolol |
| Quinidine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and other Central Nervous System (CNS) Depressants |
| Ramipril | drug interactions | Angiotensin Converting Enzyme (ACE) Inhibitors Clinical Impact: The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of aspirin due to its indirect effect on the renin-angiotensin conversion pathway. Intervention: Use caution if using concomitantly. Evaluate the blood pressure and renal function of patients. Examples: Ramipril, captopril |
| Rifampin | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine in ASCOMP with Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of ASCOMP with Codeine and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentrations of active … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of ASCOMP with Codeine and evaluate patients at frequent … |
| Ritonavir | drug interactions | Clinical Impact: The concomitant use of ASCOMP with Codeine and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the ASCOMP with Codeine dosage as … |
| Rivaroxaban | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Valproic acid | drug interactions | Anticonvulsants Clinical Impact: Aspirin can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels. Intervention: Use caution if using concomitantly. Examples: Phenytoin, valproic acid |
| Vancomycin | drug interactions | Clinical Impact: Concomitant use with aspirin may lead to additive nephrotoxicity due to the inhibition of renal prostaglandins by aspirin. Also, the plasma concentration of aspirin is increased by conditions that reduce the glomerular filtration rate or … B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, or parenteral vancomycin Angiotensin Converting Enzyme (ACE) Inhibitors |
| Warfarin | drug interactions | Clinical Impact: Aspirin may enhance the effects of anticoagulants. Concurrent use may increase the risk of bleeding. Aspirin can also displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Intervention: Evaluate patients for signs of bleeding. Warfarin, heparin, enoxaparin, clopidogrel, prasugrel, rivaroxaban, apixaban Uricosuric Agents |
Check aspirin, butalbital, caffeine and codeine against other medicines
Source: FDA drug label (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE), ANDA075231 (Lgm Pharma), as published by Bryant Ranch Prepack, effective May 27, 2026 (SPL set 95a33c9b-79a6-47c7-8433-fc217950b88f), via openFDA; the full label on DailyMed
What do FAERS reports show for aspirin, butalbital, caffeine and codeine?
The FDA Adverse Event Reporting System holds 53 reports that list aspirin, butalbital, caffeine and codeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 16 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aspirin, butalbital, caffeine and codeine?
26 other medicines are given the same way (oral) and in the same FDA class as aspirin, butalbital, caffeine and codeine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Meloxicam | Pain | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as aspirin, butalbital, caffeine and codeine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to aspirin, butalbital, caffeine and codeine
- 26 medicines for the same use
- Other barbiturates
- the pharmacologic class, with prices and generics
- Aspirin, butalbital, caffeine and codeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other