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Aspirin, Butalbital, and Caffeine

Aspirin, Butalbital, and Caffeine is a combination pain reliever, sedative-type medicine and stimulant used to relieve tension headache.

Brand names FiorinalLanorinalFarbitalFiormorFiortal +4 more
Drug classes Barbiturate
Rx Schedule CIII Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Aspirin, Butalbital, and Caffeine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Aspirin, butalbital and caffeine (Fiorinal) treats tension headache, with aspirin relieving pain and butalbital, a barbiturate sedative, easing tension and tight muscles; on the market since about 1985 and available as a generic, it is an older standby usually saved for when simpler pain relievers fall short. An occasional dose is usually well tolerated, though drowsiness, dizziness and nausea are common. The thing to watch is how often you take it, because butalbital is habit-forming and it is meant for an occasional headache, not daily or repeated use. Its aspirin also raises bleeding risk, making it a poor fit with ulcers, bleeding disorders, blood thinners or late pregnancy.

Clinical pearls

  • Skip alcohol, opioids, sleep aids and anxiety medicines while taking it, since together they can dangerously slow your breathing.
  • Avoid adding ibuprofen or naproxen, because stacking another NSAID on its aspirin raises the risk of stomach ulcers and bleeding.
  • Tell your surgeon or dentist you take it before any procedure, because the aspirin prolongs bleeding time.
  • Stop it and get help at the first rash, blistering, facial swelling or trouble breathing, which can signal a serious reaction.
How you get itPrescription only
Comes asCapsule
Earliest FDA record1985
Companies listing it with the FDA5
FDA label last updatedJun 21, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Aspirin, Butalbital, and Caffeine, written from its FDA label.

What Aspirin, Butalbital, and Caffeine is used for

▾

Aspirin, Butalbital, and Caffeine is supported here for one use:

  • Butalbital, aspirin, and caffeine oral capsules: relief of the symptom complex of tension (muscle contraction) headache.

It has not been shown to work for multiple recurrent headaches.

How Aspirin, Butalbital, and Caffeine works

▾

Aspirin provides pain relief. Butalbital, a barbiturate, adds calming and muscle-relaxing effects. Caffeine is the third ingredient.

In placebo-controlled trials, the capsules relieved headache pain, mental tension and muscle tightness in the head, neck and shoulders. A study comparing the combination with its components showed each one contributes, and the combination was significantly better than either component alone.

Aspirin, Butalbital, and Caffeine dosage

▾

The capsules are taken by mouth. The label directs one or two capsules about every 4 hours, with no more than 6 in a day.

  • Avoid extended or repeated use because of the risk of physical dependence.
  • Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Aspirin, Butalbital, and Caffeine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Aspirin, butalbital, and caffeine capsules (no specific condition named)
    • One or 2 capsules every 4 hours
    • Maximum: Total daily dose should not exceed 6 capsules
    • Extended and repeated use is not recommended because of the potential for physical dependence
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Read the full Dosage and Administration section on DailyMed →

Aspirin, Butalbital, and Caffeine side effects

▾

The most common side effects are:

Common side effects

  • Drowsiness
  • Dizziness
  • Lightheadedness
  • Nausea
  • Vomiting
  • Gas (flatulence)

When to get medical help

  • Get emergency help for signs of a severe allergic reaction, such as trouble breathing or facial swelling.
  • Stop the medicine and call your doctor right away at the first sign of a skin rash, blistering or peeling skin.
  • Call your doctor right away if you have fever, rash, swollen glands or facial swelling. These can be signs of a serious reaction called DRESS.
  • Seek help if you notice unusual bleeding.
  • Get urgent help for overdose signs: extreme drowsiness, confusion, slow breathing, ringing in the ears, vomiting, or seizures.

Rarely, serious skin reactions, DRESS and bone marrow suppression have been reported. Stop the medicine and get medical help for a rash, blistering, fever or facial swelling.

Aspirin, Butalbital, and Caffeine warnings and precautions

▾
  • Habit-forming: butalbital can be abused and cause physical dependence, so long-term use is not recommended.
  • Allergy: aspirin can cause anaphylaxis and other severe allergic reactions.
  • Bleeding: risk is higher with ulcers, other stomach lesions or bleeding disorders, and aspirin may prolong bleeding time before surgery.
  • Skin reactions and DRESS: can be serious and even fatal, and may occur without warning.
  • Reye's Syndrome: use caution in children and teens with chicken pox or flu.
  • Pregnancy: NSAIDs can cause fetal heart vessel closure at about 30 weeks or later, and fetal kidney problems with low amniotic fluid from about 20 weeks.

Aspirin, Butalbital, and Caffeine interactions

▾

This medicine can clash with several types of drugs:

  • Alcohol, opioids, tranquilizers, sedatives, anesthetics: more drowsiness and CNS depression.
  • MAO inhibitors: can enhance butalbital's brain effects.
  • Oral blood thinners: more bleeding.
  • Insulin and diabetes pills: low blood sugar if the maximum daily amount is exceeded.
  • Methotrexate, 6-mercaptopurine: bone marrow toxicity and blood problems.
  • Other NSAIDs: more ulcer and bleeding risk.
  • Corticosteroids: stopping them during chronic aspirin use may cause salicylism (aspirin toxicity).
  • Probenecid, sulfinpyrazone: less effective for gout.

Interactions listed in the FDA-approved label

From the Aspirin, Butalbital, and Caffeine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Monoamine oxidase (MAO) inhibitors: The CNS effects of butalbital may be enhanced by MAO inhibitors.
  • Corticosteroids (in patients on chronic aspirin): Withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
  • Oral anticoagulants: The capsules may enhance their effects, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites.
  • Oral antidiabetic agents and insulin: The capsules may enhance their effects, causing hypoglycemia by contributing an additive effect, if dosage exceeds maximum recommended daily dosage.
  • 6-mercaptopurine and methotrexate: The capsules may enhance their effects, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion.
  • Non-steroidal anti-inflammatory agents: The capsules may enhance their effects, increasing the risk of peptic ulceration and bleeding by contributing additive effects.
  • Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants: The capsules may enhance their effects, causing increased CNS depression.
  • Uricosuric agents such as probenecid and sulfinpyrazone: The capsules may diminish their effects, reducing their effectiveness in the treatment of gout; aspirin competes with these agents for protein binding sites.
Read the label’s full interactions text

Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. Butalbital, aspirin, and caffeine capsules may enhance the effects of: • Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites. • Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of butalbital, aspirin, and caffeine capsules exceeds maximum recommended daily dosage. • 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion. • Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects. • Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Butalbital, aspirin, and caffeine capsules may diminish the effects of: Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Aspirin, Butalbital, and Caffeine

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  • Do not use with allergy or intolerance to aspirin, caffeine or butalbital.
  • Do not use with bleeding disorders, including severe liver damage.
  • Do not use with nasal polyps, angioedema and breathing spasms triggered by aspirin or NSAIDs.
  • Do not use with a peptic ulcer or serious stomach or intestinal lesions.
  • Do not use with porphyria.
  • Be careful in children and teens with chicken pox or flu.
  • Pregnancy: avoid at about 30 weeks or later, and limit use from about 20 weeks.

Aspirin, Butalbital, and Caffeine overdose

▾

Overdose is mainly a risk from butalbital and aspirin. Signs can include drowsiness, confusion, coma, slow breathing, low blood pressure, ringing in the ears, vomiting, abdominal pain, fever and seizures. Get emergency help or contact a Poison Control Center right away.

What Aspirin, Butalbital, and Caffeine does in the body

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The capsules combine aspirin's pain relief with butalbital's calming and muscle-relaxing effects. Together they relieve headache pain, mental tension and muscle tightness in the head, neck and shoulders.

How your body processes Aspirin, Butalbital, and Caffeine

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All three ingredients are absorbed well. Aspirin peaked at about 40 minutes, butalbital at about 1.5 hours, and caffeine in under an hour in the label's studies. Aspirin has a short half-life (about 12 minutes; salicylate about 3 hours), butalbital about 35 hours and caffeine about 3 hours. The ingredients are processed mostly by the liver and cleared by the kidneys.

How to store Aspirin, Butalbital, and Caffeine

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Store and Dispense Store at 20° to 25°C (68° to 77°F). Dispense in a tight container as defined in the USP with a child-resistant closure. Protect from moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

347

Supplements & herbs that interact with Aspirin, Butalbital, and Caffeine

347 supplements and herbal products have documented interactions with Aspirin, Butalbital, and Caffeine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 13
  • Moderate · 285
  • Minor · 49
Every supplement checked against Aspirin, Butalbital, and Caffeine — ranked by severity The full interaction hub: 13 major · 285 moderate · 49 minor · every one linked to its full report. Check Aspirin, Butalbital, and Caffeine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

4

Nutrient depletion considerations

Aspirin, Butalbital, and Caffeine has been associated with lower levels of 4 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 2
  • Moderate · 2
See the full Aspirin, Butalbital, and Caffeine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Aspirin, Butalbital, and Caffeine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Aspirin, Butalbital, and Caffeine — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
It's used to relieve tension headache, also called muscle contraction headache. It hasn't been shown to work for multiple recurrent headaches, so talk with your prescriber if your headaches keep coming back.

How do I take it?

▾
You take the capsules by mouth, one or two about every 4 hours. Don't go over 6 capsules in a day. Follow your prescriber's directions and avoid using it for long stretches.

What side effects should I expect?

▾
Drowsiness and dizziness are the most common. Lightheadedness, nausea, vomiting and gas can also happen. Be careful driving until you know how it affects you.

Can I drink alcohol with it?

▾
It's best to avoid it. Alcohol and other sedating medicines, such as opioids and tranquilizers, can add to the drowsiness and slow your brain and breathing.

Is it safe in pregnancy?

▾
Talk with your prescriber first. The aspirin in it is an NSAID, which should be avoided at about 30 weeks of pregnancy or later. From about 20 weeks, it can affect the baby's kidneys, so use should be limited.

When should I call my doctor?

▾
Stop the medicine and get help right away for a rash, blistering, fever, facial swelling, trouble breathing or unusual bleeding. Also call if you feel you need it more often than prescribed, since butalbital is habit-forming.

Is Aspirin, Butalbital, and Caffeine available over the counter?

▾
No. Aspirin, Butalbital, and Caffeine is a prescription medicine: every Aspirin, Butalbital, and Caffeine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Aspirin, Butalbital, and Caffeine a controlled substance?

▾
Yes — Aspirin, Butalbital, and Caffeine is a federally controlled substance (Schedule III) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Aspirin, Butalbital, and Caffeine first available?

▾
The earliest FDA record we hold for Aspirin, Butalbital, and Caffeine is from 1985: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Aspirin, Butalbital, and Caffeine was first used.

Who makes Aspirin, Butalbital, and Caffeine?

▾
5 companies currently list Aspirin, Butalbital, and Caffeine products in the FDA's NDC Directory, including Chartwell RX, LLC, Lgm Pharma Solutions, Llc, Lannett Company, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Aspirin, Butalbital, and Caffeine on HelloPharmacist

Detailed data & references for Aspirin, Butalbital, and Caffeine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Aspirin, Butalbital, and Caffeine forms and strengths (how it comes)

Aspirin, Butalbital, and Caffeine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
How this form is used
What it may be used for
  • Butalbital, aspirin, and caffeine capsules are used to relieve tension (muscle contraction) headache.
Important instructions
  • Butalbital, aspirin, and caffeine capsules are taken by mouth, one or two capsules every 4 hours.
  • Butalbital, aspirin, and caffeine capsules should not exceed 6 capsules in a day.
  • Extended and repeated use of butalbital, aspirin, and caffeine capsules is not recommended because of the risk of physical dependence.
Available strengths 4 strengths
10 FDA-listed product records ⓘ

Aspirin, Butalbital, and Caffeine on the U.S. market: products, makers and brands

How Aspirin, Butalbital, and Caffeine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5 companies list 5 Aspirin, Butalbital, and Caffeine product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1985. Brand names on the directory include Fiorinal, Lanorinal, Farbital and 6 more; the rest are generics.

1
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
1
Brand names
5
FDA-listed product records ⓘ
1985
Earliest FDA record ⓘ
Chartwell RX, LLC20%
Lgm Pharma Solutions, Llc20%
Lannett Company, Inc.20%
Sandoz Inc20%
Westminster Pharmaceuticals, LLC20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Aspirin, Butalbital, and Caffeine is used (Medicaid data)

A general measure of how commonly Aspirin, Butalbital, and Caffeine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Aspirin, Butalbital, and Caffeine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,077
Medicaid prescriptions filled (Q1–Q4 2025)
$318,714 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Aspirin, Butalbital, and Caffeine prescribed? Of the 1,601 medications we measure, Aspirin, Butalbital, and Caffeine ranks #969 by Medicaid prescriptions — more than 39% of them.

Where Aspirin, Butalbital, and Caffeine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Aspirin, Butalbital, and Caffeine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule

8,077 Medicaid prescriptions (Q1–Q4 2025) 100% of Aspirin, Butalbital, and Caffeine prescriptions shown $318,714 gross reimbursement (before rebates) ≈ $39 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238134

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Aspirin, Butalbital, and Caffeine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 10 listed Aspirin, Butalbital, and Caffeine NDCs with Medicaid activity.

Compare Aspirin, Butalbital, and Caffeine products

A representative set of FDA-listed product records for Aspirin, Butalbital, and Caffeine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg Oral Chartwell RX, LLC ANDA View NDC →
BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg Oral Lannett Company, Inc. ANDA View NDC →
BUTALBITAL 50 mg/1; ASPIRIN 500 mg/1; CAFFEINE 40 mg Oral Lgm Pharma Solutions, Llc ANDA View NDC →
BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg Oral Sandoz Inc ANDA View NDC →
BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg Oral Westminster Pharmaceuticals, LLC ANDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Aspirin, Butalbital, and Caffeine NDCs →

Aspirin, Butalbital, and Caffeine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Aspirin, Butalbital, and Caffeine recalls since July 2021.

✅No Aspirin, Butalbital, and Caffeine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

💵 What Aspirin, Butalbital, and Caffeine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg $0.948 per capsule NDC details & price history
Capsule · Oral 325; 50; 40 mg/1; mg/1; mg $0.948 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Aspirin, Butalbital, and Caffeine brand names

Aspirin, Butalbital, and Caffeine is sold under 9 brand names in the FDA directory — Fiorinal, Lanorinal, Farbital, Fiormor and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Fiorinal Lanorinal Farbital Fiormor Fiortal Fortabs Idenal ) Isollyl Laniroif

Who makes Aspirin, Butalbital, and Caffeine: manufacturers and labelers

5 companies list Aspirin, Butalbital, and Caffeine products with the FDA. By number of product records, the largest are Chartwell RX, LLC, Lgm Pharma Solutions, Llc, Lannett Company, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Chartwell RX, LLC 1 Lgm Pharma Solutions, Llc 1 Lannett Company, Inc. 1 Sandoz Inc 1 Westminster Pharmaceuticals, LLC 1

Aspirin, Butalbital, and Caffeine drug class (RxNorm)

Aspirin, Butalbital, and Caffeine belongs to the Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Aspirin, Butalbital, and Caffeine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 21, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Aspirin, Butalbital, and Caffeine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Aspirin, Butalbital, and Caffeine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
5
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Lgm Pharma Solutions, Llc
Linked label effective
Jun 21, 2024
Composite sections available
19
Linked SPL Set ID
a1c7b964-af71-4427-8f13-73b5e69ca525
Linked SPL Document ID
1383f9e3-02c6-4363-920c-8e24e51f22e0
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lgm Pharma Solutions, Llc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →