Butalbital, Acetaminophen, and Caffeine 50 mg; 300 mg; 40 mg Capsule, 100-count — NDC 00527-4095-37 package photo

Butalbital, Acetaminophen, and Caffeine 50 mg; 300 mg; 40 mg Capsule, 100-count

by Lannett Company, Inc. · 100 CAPSULE in 1 BOTTLE (0527-4095-37)
NDC 00527-4095-37
🏷️ FDA NDC (as labeled) 0527-4095-37 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0527-4095-37
Product NDC 0527-4095
11-digit billing NDC 00527409537
NCPDP billing unit EA — each (per item)
RxCUI 889520
UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E
Application # ANDA212082
SPL Set ID 4d62259d-a582-4621-b62e-3d5640cadf7c
Established class (EPC) Barbiturate; Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Barbiturates; Xanthines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-17
Route ORAL
Dosage form CAPSULE
Substance BUTALBITAL; ACETAMINOPHEN; CAFFEINE
GPI-14 64991003100108
GPI class Butalbital-APAP-Caffeine
GCN Seq No 066372
GCN 28626
HICL code 001854
Ingredient (HICL) Butalb/Acetaminophen/Caffeine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3L
Therapeutic class — specific (HIC3) Analgesic,Non-Salicylate,Barbiturate,Xanthine Comb
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name BUTALB-ACETAMIN-CAFF 50-300-40
FDB brand name Butalbital-Acetaminophen-Caffe
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 0527-4095-37 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00527-4095-37. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLannett Company, Inc.
Application holderLANNETT CO INC
FDA applicationANDA212082 (ANDA)
Labeler code00527
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio171 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BUTALB-ACETAMIN-CAFF 50-300-40 Ingredient Butalb/Acetaminophen/Caffeine
📖 What it is MedlinePlus · NLM

Acetaminophen, butalbital, and caffeine is used to relieve tension headaches. Acetaminophen is in a class of medications called analgesics (pain relievers). It works by changing the way the body senses pain. Butalbital is in a class of medications called barbiturates. It works by having a relaxing effect on the brain and central nervous system (CNS). Caffeine is a CNS stimulant. It works by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • This combination — butalbital, acetaminophen, and caffeine — is specifically approved for tension headache, sometimes called a muscle contraction headache. It has not been shown to...
  • What exactly is this medication for, and will it work for my migraines?
  • Yes, that's worth taking seriously. Butalbital — one of the three ingredients — is a barbiturate, a type of sedative that your body can become physically dependent on over time. Th...
  • Is it true this medication can be habit-forming?
📖 Read our full Acetaminophen, Butalbital, and Caffeine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeCapsule
ImprintLannett;4095
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

20 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.316 $31.61 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.7112 $71.12 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.6493 $64.93 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.789 $0.311
▼ Down 60% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Butalbital, Acetaminophen, and Caffeine 50 mg/1; 300 mg/1; 40 mgthis 00527-4095-37 Lannett 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen, and Caffeine 50 mg/1; 300 mg/1; 40 mg 00591-2640-01 Actavis 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen And Caffeine 300 mg/1; 40 mg/1; 50 mg 11534-0187-01 SUNRISE 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen And Caffeine 50 mg/1; 300 mg/1; 40 mg 43547-0686-10 SOLCO 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen and Caffeine 50 mg/1; 300 mg/1; 40 mg 51672-4222-01 Sun 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen and Caffeine 50 mg/1; 300 mg/1; 40 mg 70010-0044-01 Granules 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen And Caffeine 50 mg/1; 300 mg/1; 40 mg 70752-0144-10 QUAGEN 100 capsules $0.316 AA Availability likely
Butalbital, Acetaminophen, and Caffeine 300 mg/1; 50 mg/1; 40 mg 16714-0170-01 NORTHSTAR 100 capsules $0.336 AA Discontinued +6%
Fioricet 50 mg/1; 300 mg/1; 40 mg 52544-0080-01 Actavis 100 capsules $8.824 AA Availability likely +2691%
Butalbital, Acetaminophen And Caffeine 50 mg/1; 300 mg/1; 40 mg 13925-0535-01 Seton 100 capsules AA FDA listed
Butalbital, Acetaminophen, and Caffeine 50 mg/1; 300 mg/1; 40 mg 42291-0181-01 AvKARE 100 capsules AA FDA listed
Butalbital, Acetaminophen And Caffeine 300 mg/1; 40 mg/1; 50 mg 63629-2372-01 Bryant 100 capsules AA FDA listed
Butalbital, Acetaminophen And Caffeine 300 mg/1; 40 mg/1; 50 mg 72162-1232-01 Bryant 100 capsules AA FDA listed
Butalbital/Acetaminophen/Caffeine 50 mg/1; 300 mg/1; 40 mg 80425-0215-01 Advanced 30 capsules AA FDA listed
Butalbital, Acetaminophen And Caffeine 50 mg/1; 300 mg/1; 40 mg 80425-0497-01 Advanced 30 capsules AA FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00527-4095-37, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.4K
Units reimbursed last 4 qtrs
59.4K
Gross reimbursed last 4 qtrs
$42.3K
Avg / prescription
$31.20
Avg / unit
$0.7112
Latest quarter Q4 2025
283Rx
Medicaid pays / ea
$0.7112
gross reimbursed
vs
NADAC / ea
$0.3161
acquisition cost
=
Spread
+$0.3951
+125% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
61% FFS 39% MCO
Fee-for-service · 829 Rx Managed care · 525 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 5,083 units · 50.6 per 100k residents MI New York: 23,530 units · 120 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 492 units · 3.9 per 100k residents IL Indiana: 1,411 units · 20.6 per 100k residents IN Ohio: 1,726 units · 14.6 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,680 units · 6.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,353 units · 29.9 per 100k residents KY West Virginia: 617 units · 34.9 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 3,453 units · 95.5 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,367 units · 19.2 per 100k residents TN North Carolina: 6,834 units · 63.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,750 units · 38.3 per 100k residents LA Mississippi: no data reported MS Alabama: 202 units · 4.0 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,522 units · 27.9 per 100k residents TX Florida: 385 units · 1.7 per 100k residents FL
Units reimbursed · per 100k residents
1.7120
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 120 /100k
2 Connecticut 95.5 /100k
3 North Carolina 63.1 /100k
4 Michigan 50.6 /100k
5 Louisiana 38.3 /100k
6 West Virginia 34.9 /100k
7 Kentucky 29.9 /100k
8 Texas 27.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00527-4095-37 You're viewing this 100 CAPSULE in 1 BOTTLE (0527-4095-37) 2019-12-17 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 50 words

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

🎯 Indications and Usage 55 words

INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

⏱️ Dosage and Administration 37 words

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

Contraindications 23 words

CONTRAINDICATIONS This product is contraindicated under the following conditions: – Hypersensitivity or intolerance to any component of this product – Patients with porphyria.

⚠️ Warnings ~3 min read

BOXED WARNING Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

WARNINGS Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.

Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Hypersenitivity/ anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.

There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Butalbital, Acetaminophen and Caffeine Capsules, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Capsules, USP for patients with acetaminophen allergy.

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersenitivity/ anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of…

🤒 Adverse Reactions 168 words

ADVERSE REACTIONS Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure.

Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product.

Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

🔄 Drug Interactions 43 words

Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

🔄 Drug / Laboratory Test Interactions 13 words

Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

🤰 Pregnancy 101 words

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

🧒 Pediatric Use 17 words

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

🧓 Geriatric Use 141 words

Geriatric Use Clinical studies of butalbital, acetaminophen and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read

OVERDOSAGE Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation. Signs and Symptoms Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise.

Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles. Treatment A single or multiple overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.

Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY This combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics The behavior of the individual components is described below. Butalbital Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier.

They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility. Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours.

Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated. The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL.

This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells. See OVERDOSAGE for toxicity information.

Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites.

Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information. Caffeine Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid.

Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug. See OVERDOSAGE for toxicity information.

📦 How Supplied / Storage and Handling 97 words

HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Capsules, USP 50 mg/300 mg/40 mg Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as size 0 capsule with opaque blue cap imprinted in white with “ Lannett ” and opaque aqua blue body imprinted with “4095” in white and filled with powder. The capsules are supplied in bottles of 100 capsules (NDC 0527-4095-37).

Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container. Rx only Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB71940C Rev.

07/23

📋 Description 143 words

DESCRIPTION Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: butalbital USP……………………50 mg acetaminophen USP…………….300 mg caffeine USP……………………..40 mg Inactive Ingredients: pregelatinized starch, talc, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black iron oxide, yellow iron oxide, FD&C blue #1. Imprinting ink composed of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide, ammonium hydroxide, and simethicone.

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula: Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19.

It has the following structural formula: Butalbital Molecule Acetaminophen Molecule Caffeine Molecule

💬 Information for Patients 160 words

Information for Patients This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use .

Do not take Butalbital, Acetaminophen, and Caffeine Capsules if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Butalbital, Acetaminophen, and Caffeine Capsules and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day.

Call your doctor if you took more than the recommended dose.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.