Butalbital, Acetaminophen, Caffeine description, usages, side effects, indications, overdosage, supplying and lots more!

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Butalbital, Acetaminophen, Caffeine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.


BUTALBITAL, ACETAMINOPHEN, CAFFEINE DESCRIPTION



Butalbital, Acetaminophen, Caffeine


Butalbital, Acetaminophen, Caffeine


Butalbital, Acetaminophen, Caffeine







CLINICAL PHARMACOLOGY




Pharmacokinetics


Butalbital



OVERDOSAGE

Acetaminophen

OVERDOSAGE

Caffeine


OVERDOSAGE

INDICATIONS & USAGE




BUTALBITAL, ACETAMINOPHEN, CAFFEINE CONTRAINDICATIONS





WARNINGS

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.
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, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets, USP for patients with acetaminophen allergy.



PRECAUTIONS

General


INFORMATION FOR PATIENTS

  • ●     Do not take Butalbital, Acetaminophen and Caffeine Tablets, USP 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, USP 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.




LABORATORY TESTS



DRUG INTERACTIONS




DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Teratogenic Effects


Nonteratogenic Effects


NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE




BUTALBITAL, ACETAMINOPHEN, CAFFEINE ADVERSE REACTIONS

Frequently Observed

Infrequently Observed









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 theOVERDOSAGEsection.



DRUG ABUSE AND DEPENDENCE

Abuse and Dependence

Butalbital



OVERDOSAGE



Signs and Symptoms
barbiturate
acetaminophen
caffeine

Treatment





DOSAGE & ADMINISTRATION




HOW SUPPLIED

Butalbital, Acetaminophen and Caffeine Tablets, USP


STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Butalbital, Acetaminophen, Caffeine

Butalbital, Acetaminophen, Caffeine

Butalbital, Acetaminophen, Caffeine

Butalbital, Acetaminophen, Caffeine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-823(NDC:0603-2545)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUTALBITAL BUTALBITAL 50 mg
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 40 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
cellulose, microcrystalline
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 20 mm 23;57;V OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-823-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040513 2011-11-10


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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