Butalbital
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Questions & Answers
Side Effects & Adverse Reactions
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.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
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.
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.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 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.
History
There is currently no drug history available for this drug.
Other Information
Butalbital, acetaminophen and caffeine are supplied in tablet form for oral administration.
Each tablet contains the following active ingredients:
Butalbital ...................50 mg
Warning: May be habit-forming.
Acetaminophen ........325 mg
Caffeine ......................40 mg
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized corn starch and stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate acting barbiturate. It has the following structural formula:
C11H16N2O3 MW = 224.26
Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 MW = 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 MW = 194.19
Sources
Butalbital Manufacturers
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Remedyrepack Inc.
![Butalbital, Acetaminophen And Caffeine Tablet [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Butalbital | Remedyrepack Inc.
One or two tablets every four 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.
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Lake Erie Medical Dba Quality Care Products Llc
Butalbital | Lake Erie Medical Dba Quality Care Products Llc
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.
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American Health Packaging
Butalbital | American Health Packaging
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.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of Butalbital, Acetaminophen, and Caffeine Tablets USP is not recommended because of the potential for physical dependence.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
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.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
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.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
One or 2 capsules every 4 hours. 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.
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Direct Rx
Butalbital | Baxter Healthcare Corporation
2.1 Intravenous DosingMesna may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.
Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.
* The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.Table 1. Recommended Intravenous Dosing Schedule
0 Hours
4 Hours
8 Hours
Ifosfamide
1.2 g/m2
–
–
Mesna injection*
240 mg/m2
240 mg/m2
240 mg/m2
2.2 Intravenous and Oral DosingMesna may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of MESNEX tablets as outlined below.
Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. MESNEX tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.
* The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.Table 2. Recommended Intravenous and Oral Dosing Schedule
0 Hours
2 Hours
6 Hours
Ifosfamide
1.2 g/m2
–
–
Mesna injection*
240 mg/m2
–
–
MESNEX tablets
–
480 mg/m2
480 mg/m2
The efficacy and safety of this ratio of intravenous mesna and oral MESNEX has not been established as being effective for daily doses of ifosfamide higher than 2 g/m2.
Patients who vomit within two hours of taking oral MESNEX should repeat the dose or receive intravenous mesna.
2.3 Monitoring for HematuriaMaintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when mesna is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.
2.4 Preparation for Intravenous Administration and StabilityPreparation
Determine the volume of mesna injection for the intended dose.
Dilute the volume of mesna injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:
• 5% Dextrose Injection, USP • 5% Dextrose and 0.2% Sodium Chloride Injection, USP • 5% Dextrose and 0.33% Sodium Chloride Injection, USP • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 0.9% Sodium Chloride Injection, USP • Lactated Ringer’s Injection, USPStability
The mesna injection multidose vials may be stored and used for up to 8 days after initial puncture.
Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.
Do not mix mesna injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.
The benzyl alcohol contained in mesna injection vials can reduce the stability of ifosfamide. Ifosfamide and mesna may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with mesna and may reduce the stability of ifosfamide.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.
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Avkare, Inc.
Butalbital | Kinray
• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctorTo spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.
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Mutual Pharmaceutical Company, Inc.
Butalbital | Mutual Pharmaceutical Company, Inc.
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.
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Jerome Stevens Pharmaceuticals
Butalbital | Jerome Stevens Pharmaceuticals
1 or 2 capsules every 4 hours. 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.
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Actavis Elizabeth Llc
Butalbital | Actavis Elizabeth Llc
One or 2 tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Qualitest
Butalbital | Qualitest
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Breckenridge Pharmaceutical, Inc.
Butalbital | Breckenridge Pharmaceutical, Inc.
One or two capsules every four hours. Total daily dosage should not exceed six capsules.
Extended and repeated use of this combination product is not recommended because of the potential for physical dependence.
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Rising Pharmaceuticals, Inc.
Butalbital | Rising Pharmaceuticals, Inc.
One or Two tablets every four (4) hours as needed. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Rising Pharmaceuticals, Inc.
Butalbital | Rising Pharmaceuticals, Inc.
One tablet every four (4) hours. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Physicians Total Care, Inc.
Butalbital | Physicians Total Care, Inc.
One or 2 capsules every 4 hours. 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.
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Physicians Total Care, Inc.
Butalbital | Physicians Total Care, Inc.
One or 2 capsules every 4 hours. 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.
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Keltman Pharmaceuticals Inc.
Butalbital | Keltman Pharmaceuticals Inc.
Oral: one tablet every four hours. 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.
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Stat Rx Usa Llc
Butalbital | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATIONOne tablet every 4 hours. 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.
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Stat Rx Usa Llc
Butalbital | Stat Rx Usa Llc
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.
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Lannett Company, Inc.
Butalbital | Lannett Company, Inc.
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.
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Rebel Distributors Corp
Butalbital | Rebel Distributors Corp
Oral: One or two tablets every four hours as needed. Do not exceed 6 tablets per day.
Medication should be taken with food or a full glass of water or milk to lessen gastric irritation caused by aspirin.
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Physicians Total Care, Inc.
Butalbital | Physicians Total Care, Inc.
Oral: One or two tablets every four hours. 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.
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Rebel Distributors Corp
Butalbital | Rebel Distributors Corp
Oral: One or two tablets every four hours. 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.
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Rebel Distributors Corp.
Butalbital | Rebel Distributors Corp.
Oral: one tablet every four hours. 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.
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Cardinal Health
Butalbital | Cardinal Health
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.
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Victory Pharmaceutical
Butalbital | Victory Pharmaceutical
Oral: one capsule every four hours. 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.
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Mirror Pharmaceuticals Llc
Butalbital | Mirror Pharmaceuticals Llc
One tablet every four (4) hours. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Mirror Pharmaceuticals Llc
Butalbital | Mirror Pharmaceuticals Llc
One tablet every four (4) hours. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Redpharm Drug Inc.
Butalbital | Redpharm Drug Inc.
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.
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Dispensing Solutions, Inc.
Butalbital | Dispensing Solutions, Inc.
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Dispensing Solutions, Inc.
Butalbital | Dispensing Solutions, Inc.
One or two capsules every four hours. Total daily dosage should not exceed six capsules.
Extended and repeated use of this combination product is not recommended because of the potential for physical dependence.
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Pd-rx Pharmaceuticals, Inc.
Butalbital | Safeway
drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor -
Remedyrepack Inc.
Butalbital | Remedyrepack Inc.
One tablet every 4 hours. 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.
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H.j. Harkins Company, Inc.
Butalbital | H.j. Harkins Company, Inc.
One tablet every 4 hours. 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.
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Rebel Distributors Corp
Butalbital | Rebel Distributors Corp
Oral: one tablet every four hours. Total daily dosage should not exceed 5 tablets.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Pd-rx Pharmaceuticals, Inc.
Butalbital | Pd-rx Pharmaceuticals, Inc.
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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H.j. Harkins Company
Butalbital | H.j. Harkins Company
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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West-ward Pharmaceutical Corp
Butalbital | West-ward Pharmaceutical Corp
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Butalbital | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Stat Rx Usa Llc
Butalbital | Stat Rx Usa Llc
Oral: One or two tablets every four hours. 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.
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Golden State Medical Supply, Inc.
Butalbital | Golden State Medical Supply, Inc.
Oral: one tablet every four hours. 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.
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Lannett Company, Inc.
Butalbital | Lannett Company, Inc.
1 or 2 capsules every 4 hours. 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.
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Cardinal Health
Butalbital | Cardinal Health
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.
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Cardinal Health
Butalbital | Cardinal Health
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.
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Bryant Ranch Prepack
Butalbital | Bryant Ranch Prepack
One or 2 capsules every 4 hours. 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.
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Bryant Ranch Prepack
Butalbital | Bryant Ranch Prepack
One or 2 capsules every 4 hours. 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.
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Bryant Ranch Prepack
Butalbital | Bryant Ranch Prepack
One tablet every four (4) hours. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Lannett Company, Inc.
Butalbital | Lannett Company, Inc.
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.
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Rebel Distributors Corp
Butalbital | Rebel Distributors Corp
One tablet every 4 hours. 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.
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Bryant Ranch Prepack
Butalbital | Bryant Ranch Prepack
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
One or two tablets every 4 hours. Total daily dose should not exceed 6 tablets.
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Remedyrepack Inc.
Butalbital | Remedyrepack Inc.
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.
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Lake Erie Medical Dba Quality Care Products Llc
Butalbital | Lake Erie Medical Dba Quality Care Products Llc
One tablet every 4 hours. 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.
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Remedyrepack Inc.
Butalbital | Remedyrepack Inc.
One or two tablets every four 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.
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Unit Dose Services
Butalbital | Unit Dose Services
One or two tablets every four 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.
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Watson Pharma, Inc.
Butalbital | Kroger Company
• adults and children 12 years and over: • do not swallow tablet whole: chew completely • to relieve symptoms, chew 1 tablet before swallowing • do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor -
Kaiser Foundation Hospitals
Butalbital | Kaiser Foundation Hospitals
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.
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Watson Pharma, Inc.
Butalbital | Par Pharmaceutical Inc.
The recommended starting adult dose for all QUESTRAN powdered products (QUESTRAN Powder and QUESTRAN Light) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all QUESTRAN powdered products is 2 to 4 packets or scoopfuls daily (8-16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of QUESTRAN as follows:
QUESTRAN Powder
9 grams
QUESTRAN Light
5 grams
It is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks. The maximum recommended daily dose is six packets or scoopfuls of QUESTRAN (24 grams of anhydrous cholestyramine resin). The suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. Although the recommended dosing schedule is twice daily, QUESTRAN may be administered in 1–6 doses per day.
QUESTRAN should not be taken in its dry form. Always mix QUESTRAN with water or other fluids before ingesting. See Preparation Instructions.
Concomitant TherapyPreliminary evidence suggests that the lipid-lowering effects of QUESTRAN on total and LDL-cholesterol are enhanced when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin, and fluvastatin. Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/QUESTRAN therapy. See the Drug Interactions subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy.
PREPARATIONThe color of QUESTRAN may vary somewhat from batch to batch but this variation does not affect the performance of the product. Place the contents of one single-dose packet or one level scoopful of QUESTRAN in a glass or cup. Add an amount of water or other noncarbonated beverage of your choice depending on the product being used:
Product Formula
Amount of Water or other Non-Carbonated Liquid
QUESTRAN Powder
2-6 ounces per dose
QUESTRAN LIGHT
2-6 ounces per dose
Stir to a uniform consistency and drink.
QUESTRAN may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.
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A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
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.
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Qualitest Pharmaceuticals
Butalbital | Qualitest Pharmaceuticals
One or 2 capsules every 4 hours. 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.
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Mikart, Inc.
Butalbital | Mikart, Inc.
One or two tablets every four 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.
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Libertas Pharma, Inc.
Butalbital | Libertas Pharma, Inc.
One or two capsules every four hours. 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.
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West-ward Pharmaceutical Corp
Butalbital | West-ward Pharmaceutical Corp
Oral: one tablet every four hours. 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.
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West-ward Pharmaceutical Corp
Butalbital | West-ward Pharmaceutical Corp
Oral: one capsule every four hours. 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.
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Mikart, Inc.
Butalbital | Mikart, Inc.
One or two tablespoonfuls (15 mL or 30 mL) every four hours. Total daily dosage should not exceed 6 tablespoonfuls.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Mikart, Inc.
Butalbital | Mikart, Inc.
One or two capsules every four hours. 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.
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Remedyrepack Inc.
Butalbital | Remedyrepack Inc.
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.
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Aidarex Pharmaceuticals Llc
Butalbital | Aidarex Pharmaceuticals Llc
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.
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West-ward Pharmaceutical Corp
Butalbital | West-ward Pharmaceuticals Corp
one or two capsules every four hours. 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.
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Nexgen Pharma, Inc.
Butalbital | E.r. Squibb & Sons, L.l.c.
2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial FibrillationThe recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.
The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with at least two of the following characteristics:
● age ≥80 years ● body weight ≤60 kg ● serum creatinine ≥1.5 mg/dL Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement SurgeryThe recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
● In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. ● In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days. Treatment of DVT and PEThe recommended dose of ELIQUIS is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily.
Reduction in the Risk of Recurrence of DVT and PEThe recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies (14.3)].
2.2 Missed DoseIf a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
2.3 Temporary Interruption for Surgery and Other InterventionsELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
2.4 Converting from or to ELIQUISSwitching from warfarin to ELIQUIS: Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.
Switching from ELIQUIS to warfarin: ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching from ELIQUIS to anticoagulants other than warfarin (oral or parenteral): Discontinue ELIQUIS and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of ELIQUIS.
Switching from anticoagulants other than warfarin (oral or parenteral) to ELIQUIS: Discontinue the anticoagulant other than warfarin and begin taking ELIQUIS at the usual time of the next dose of the anticoagulant other than warfarin.
2.5 Strong Dual Inhibitors of CYP3A4 and P-glycoproteinFor patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) [see Clinical Pharmacology (12.3)].
In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp [see Drug Interactions (7.1)].
2.6 Administration OptionsFor patients who are unable to swallow whole tablets, 5 mg and 2.5 mg ELIQUIS tablets may be crushed and suspended in 60 mL D5W and immediately delivered through a nasogastric tube (NGT) [see Clinical Pharmacology (12.3)]. Information regarding the administration of crushed and suspended ELIQUIS tablets swallowed by mouth is not available.
2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial FibrillationThe recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.
The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with at least two of the following characteristics:
● age ≥80 years ● body weight ≤60 kg ● serum creatinine ≥1.5 mg/dL Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement SurgeryThe recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
● In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. ● In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days. Treatment of DVT and PEThe recommended dose of ELIQUIS is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily.
Reduction in the Risk of Recurrence of DVT and PEThe recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies (14.3)].
2.2 Missed DoseIf a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
2.3 Temporary Interruption for Surgery and Other InterventionsELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
2.4 Converting from or to ELIQUISSwitching from warfarin to ELIQUIS: Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.
Switching from ELIQUIS to warfarin: ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching from ELIQUIS to anticoagulants other than warfarin (oral or parenteral): Discontinue ELIQUIS and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of ELIQUIS.
Switching from anticoagulants other than warfarin (oral or parenteral) to ELIQUIS: Discontinue the anticoagulant other than warfarin and begin taking ELIQUIS at the usual time of the next dose of the anticoagulant other than warfarin.
2.5 Strong Dual Inhibitors of CYP3A4 and P-glycoproteinFor patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) [see Clinical Pharmacology (12.3)].
In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp [see Drug Interactions (7.1)].
-
Aphena Pharma Solutions – Tennessee, Llc
Butalbital | Aphena Pharma Solutions - Tennessee, Llc
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.
-
Nexgen Pharma, Inc.
Butalbital | Nexgen Pharma, Inc.
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.
-
Nexgen Pharma, Inc.
Butalbital | Nexgen Pharma, Inc.
One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this combination product is not recommended because of the potential for physical dependence.
-
Carilion Materials Management
Butalbital | Carilion Materials Management
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.
-
Bryant Ranch Prepack
Butalbital | Bryant Ranch Prepack
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.
-
Preferred Pharmaceuticals, Inc.
Butalbital | Preferred Pharmaceuticals, Inc.
One or two tablets every four 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.
-
Actavis Pharma, Inc.
Butalbital | Actavis Pharma, Inc.
One or 2 capsules every 4 hours. 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.
-
Actavis Pharma, Inc.
Butalbital | Actavis Pharma, Inc.
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.
-
American Health Packaging
Butalbital | American Health Packaging
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.
-
West-ward Pharmaceutical Corp
Butalbital | West-ward Pharmaceutical Corp
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.
-
Qualitest Pharmaceuticals
Butalbital | Qualitest Pharmaceuticals
Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:
Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mgThe usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
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Actavis Pharma, Inc.
Butalbital | La Prairie, Inc
Apply Daily After Cleansing and Toning
Smooth over face and throat
Apply liberally 15 minutes before sun exposure
Children under 6 months of age: Ask a doctor
Reapply at least every 2 hours
Use a water resistance sunscreen if swimming or sweating
-
Actavis Pharma, Inc.
Butalbital | Actavis Pharma, Inc.
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of Butalbital, Acetaminophen, and Caffeine Tablets USP is not recommended because of the potential for physical dependence.
-
Preferred Pharmaceuticals, Inc.
Butalbital | Preferred Pharmaceuticals, Inc.
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.
-
A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
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.
-
A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
One or 2 capsules every 4 hours. 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.
-
A-s Medication Solutions Llc
Butalbital | A-s Medication Solutions Llc
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.
![Butalbital, Aspirin, And Caffeine Capsule [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e334b580-ffc9-4ec7-836b-31b2211c730f&name=Butalbitallabel.jpg)
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