MARGESIC butalbital acetaminophen and caffeine capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK)

MAH:

Marnel Pharmaceuticals, LLC

INN:

BUTALBITAL

composition:

BUTALBITAL 50 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

MARGESIC- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE
MARNEL PHARMACEUTICALS, LLC
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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.
DESCRIPTION
Butalbital, acetaminophen and caffeine are supplied in capsule form
for oral administration.
Each capsule contains:
Butalbital ................... 50 mg
WARNING: May be habit-forming.
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate. microcrystalline cellulose
with capsule shell composed
of gelatin (silicon dioxide and sodium lauryl sulfate are added as
manufacturing aides) and titanium
dioxide. Imprinting ink composed of n-butyl alcohol, pharmaceutical
glaze modified in SD-45,
propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10
Aluminum Lake and FD&C
Blue No. 1 Aluminum Lake.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter,
white, odorless, crystalline powder, is a
short to intermediate-acting barbiturate. It has the following
structural formula:
C H N O MW = 224 .26
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula:
11
16
2
3
C H NO MW = 151.16
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or
white-glistening needles, is a central
nervous system stimulant. It has the following structural formula:
C H N O MW = 194 .19
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 rel