butalbital, acetaminophen and caffeine 50 mg; 325 mg; 40 mg Tablet, 100-count — NDC 70010-149-01 (Billing 70010-0149-01)
This is a package of 100 tablets of butalbital, acetaminophen and caffeine 50 mg; 325 mg; 40 mg Tablet from Granules Pharmaceuticals Inc., marketed since Jun 2022 and currently FDA-listed; retail pharmacies pay about $0.1223 per tablet (NADAC).
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004451
- GCN: 72530
- GPI-14 (Medi-Span): 64991003100310
- HICL (First Databank): 001854
- AHFS class code: 28:08.16.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Acetaminophen, butalbital, and caffeine is used to relieve tension headaches. Acetaminophen, butalbital, and caffeine is in a class of medications called combination analgesics (pain relievers). This medication works by decreasing pain, slowing the nervous system, and narrowing swollen blood vessels in the head to provide tension headache relief.
Read the full MedlinePlus article ↗- Yes, that's exactly what it's intended for. This combination of butalbital, acetaminophen, and caffeine is prescribed specifically to relieve tension headaches — the kind caused by...
- What exactly is this medication for? My doctor prescribed it for headaches — is that normal?
- This is actually something to be careful about. Butalbital, one of the ingredients, is habit-forming — meaning your body can become physically dependent on it if you take it freque...
- Can I take this regularly if I get headaches a lot?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.122 | $12.23 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3126 | $31.26 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2851 | $28.51 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 70010-0149-01 You're viewing this | 100 TABLET in 1 BOTTLE | $0.1223 / ea | $12.23 | 2022-06-29 | — | Active |
| 70010-0149-05 70010-149-05 Main listing | 500 TABLET in 1 BOTTLE | $0.1223 / ea | $61.16 | 2022-06-29 | — | Active |
| 70010-0149-49 70010-149-49 | 25500 TABLET in 1 DRUM | — | — | — | — | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1223 NADAC).
This pack accounts for about 37% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 70010-0149-05?
What NDC number is used to bill for this package of butalbital, acetaminophen and caffeine 50 mg; 325 mg; 40 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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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.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full FDA label FDA SPL
🚨 Boxed Warning ▾
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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets 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 ▾
DOSAGE AND ADMINISTRATION One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
⛔ Contraindications ▾
CONTRAINDICATIONS This product is contraindicated under the following conditions: –Hypersensitivity or intolerance to any component of this product –Patients with porphyria.
⚠️ Warnings ▾
WARNINGS Butalbital is habit-forming and potentially abusable. Consequently, the extended use of butalbital, acetaminophen, and caffeine tablets 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. Hypersensitivity/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 Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets for patients with acetaminophen allergy.
🤒 Adverse Reactions ▾
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.
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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 ▾
DRUG/LABORATORY TEST INTERACTIONS Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
PREGNANCY Teratogenic Effects Animal reproduction studies have not been conducted with butalbital, acetaminophen, and caffeine tablets. 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 ▾
PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 12 have not been established.
🧓 Geriatric Use ▾
GERIATRIC USE Clinical studies of butalbital, acetaminophen and caffeine tablets 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 ▾
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 includes 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 coagulation defects 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 drug overdose with butalbital, acetaminophen, and caffeine tablets 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 ▾
CLINICAL PHARMACOLOGY Butalbital, acetaminophen, and caffeine tablets 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 to 20 mcg/mL.
This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasmato- 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 ▾
HOW SUPPLIED Butalbital, Acetaminophen and Caffeine Tablets USP, 50 mg/325 mg/40 mg Each Butalbital, Acetaminophen, and Caffeine Tablet contains butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg. Tablets are White to off-white, round shaped tablets debossed with ‘G 149’ on one side and plain on other side. • Bottles of 100: NDC 70010-149-01 • Bottles of 500: NDC 70010-149-05 Store and Dispense Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP.
Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Revised: 04/2022 LB0034-02
📋 Description ▾
DESCRIPTION Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: Butalbital, USP..............................................................50 mg Acetaminophen, USP....................................................325 mg Caffeine, USP................................................................40 mg Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate and magnesium stearate. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate.
It has the following structural formula: C 11 H 16 N 2 O 3 M.W. = 224.26 Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8 H 9 NO 2 M.W. = 151.16 Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.
It has the following structural formula: C 8 H 10 N 4 O 2 M.W. = 194.19 Fig-1 Fig-2 Fig-3
💬 Information for Patients ▾
INFORMATION FOR PATIENTS/CAREGIVERS • Do not take Butalbital, Acetaminophen and Caffeine Tablets 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 Tablets 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. • Butalbital, acetaminophen and caffeine tablets 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 butalbital, acetaminophen, and caffeine tablets, 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 .
⚠️ Precautions ▾
PRECAUTIONS GENERAL Butalbital, acetaminophen and caffeine tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions. INFORMATION FOR PATIENTS/CAREGIVERS • Do not take Butalbital, Acetaminophen and Caffeine Tablets 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 Tablets 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. • Butalbital, acetaminophen and caffeine tablets 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 butalbital, acetaminophen, and caffeine tablets, 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 .
LABORATORY TESTS In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. 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 Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility. PREGNANCY Teratogenic Effects Animal reproduction studies have not been conducted with butalbital, acetaminophen, and caffeine tablets.
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. NURSING MOTHERS Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known.
Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 12 have not been established. GERIATRIC USE Clinical studies of butalbital, acetaminophen and caffeine tablets 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 dec… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
NURSING MOTHERS Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Abuse and Dependence Butalbital Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold.
As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs.
Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbituratedependent patients can be withdrawn by using a number of different withdrawal regimens.
One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100-labe 500-labe
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About this NDC listing & data coverage
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Granules Pharmaceuticals Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |