Prescription medicine
Acetaminophen, butalbital, caffeine and codeine
Acetaminophen, butalbital, caffeine and codeine is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.798 per butalbital-acetaminophen-caffeine-codeine 50-325-40-30 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the acetaminophen, butalbital, caffeine and codeine FDA label on DailyMed (effective January 9, 2026, Actavis Pharma, Inc.); the NDA 20232 record on Drugs@FDA; every acetaminophen, butalbital, caffeine and codeine label on DailyMed.
Highlights of the record
FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES.
Addiction, Abuse, and Misuse Because the use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 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 and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, especially by children, can result in a fatal overdose of codeine [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageButalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are 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
- 30 mg / 50 mg / 40 mg / 325 mg
- 50 mg / 325 mg / 40 mg / 30 mg
- 50 mg / 300 mg / 40 mg / 30 mg
Capsule.
On the market
- Earliest approval on file
- July 30, 1992 Fioricet W/ Codeine, Actavis Labs Ut Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first March 23, 2001; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.798 per capsule Butalbital-acetaminophen-caffeine-codeine 50-325-40-30 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 38 through July 30, 2026
What is acetaminophen, butalbital, caffeine and codeine used for?
From the label: indications and usageButalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. […]
Conditions named in the indications of acetaminophen, butalbital, caffeine and codeine's FDA labels, with every medicine labeled for each:
From other acetaminophen, butalbital, caffeine and codeine labelsPain: … ffeine, and Codeine Phosphate Capsules, 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 and Opioid Agonist.
Source: FDA drug label (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate), Actavis Pharma, Inc., effective January 9, 2026 (SPL set a58819b8-a52c-44a7-9ab0-c74480d98506), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen, butalbital, caffeine and codeine?
The FDA approved the first generic acetaminophen, butalbital, caffeine and codeine on March 23, 2001. 7 generic applications are approved; 3 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 acetaminophen, butalbital, caffeine and codeine from 5 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.
- 1992 earliest approval on file
- 2001 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen, butalbital, caffeine and codeine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.798 per Butalbital-acetaminophen-caffeine-codeine 50-325-40-30 mg capsule, down 9% from $0.879 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.
- Butalbital-acetaminophen-caffeine-codeine 50-325-40-30 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Butalbital-acetaminophen-caffeine-codeine 50-300-40-30 mg capsule | Generic | $5.30 per capsule | $158.91 | +1% |
| Butalbital-acetaminophen-caffeine-codeine 50-325-40-30 mg capsule | Generic | $0.798 per capsule | $23.94 | -9% |
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 acetaminophen, butalbital, caffeine and codeine label say about other medicines?
The acetaminophen, butalbital, caffeine and codeine label names 32 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 |
|---|---|---|
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in … |
| Buprenorphine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … other opioids (such as oxycodone, hydrocodone, oxymorphone, hydromorphone, 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 is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … 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 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Butalbital, Acetaminophen, Caffeine, and Codeine … |
| 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 … |
| Erythromycin | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting … Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice |
| Fluoxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … and symptoms of respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and Other Central Nervous System (CNS) Depressants |
| Gabapentin | 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, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| 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, hydromorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS … |
| Hydromorphone | 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, hydromorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Ketoconazole | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting … Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice |
| 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 … |
Every other medicine the acetaminophen, butalbital, caffeine and codeine label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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). |
| 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 affect 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 [see Warnings and Precautions ( 5.7 )]. |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | 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). |
| Naloxone | warnings and precautions | 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). |
| 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, hydromorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs 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, hydromorphone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and … |
| Paroxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … 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 | warnings and precautions | … a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome P450 2D6 … |
| Pregabalin | 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, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Quinidine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … respiratory depression or sedation. Examples: paroxetine, fluoxetine, bupropion, quinidine Benzodiazepines and Other Central Nervous System (CNS) Depressants |
| Rifampin | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Butalbital, Acetaminophen, Caffeine, and Codeine … |
| Ritonavir | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with CYP3A4 inhibitors may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting … azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice |
| 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. … affect 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 affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Check acetaminophen, butalbital, caffeine and codeine against other medicines
Source: FDA drug label (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate), Actavis Pharma, Inc., effective January 9, 2026 (SPL set a58819b8-a52c-44a7-9ab0-c74480d98506), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen, butalbital, caffeine and codeine?
The FDA Adverse Event Reporting System holds 38 reports that list acetaminophen, 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; 12 are coded as a death and 1 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 acetaminophen, butalbital, caffeine and codeine?
27 other medicines are given the same way (oral) and in the same FDA class as acetaminophen, 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 |
|---|---|---|---|---|
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
| Tapentadol | Pain | 4 labelers | $14.48 per tablet 100 mg tablet | No current entry |
| Hydrocodone | Pain | 1 labeler | $7.95 per capsule 15 mg capsule | No current entry |
Every medicine labeled for the same conditions as acetaminophen, 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 acetaminophen, butalbital, caffeine and codeine
- 27 medicines for the same use
- Other barbiturates
- the pharmacologic class, with prices and generics
- Acetaminophen, 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