ISOMETHEPTENE-DICHLORAL-APAP ORAL mucate dichloralphenazone and acetaminophen capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ISOMETHEPTENE MUCATE (UNII: 8O120FDS6P) (ISOMETHEPTENE - UNII:Y7L24THH6T)

Disponibil de la:

Method Pharmaceuticals, LLC

INN (nume internaţional):

ISOMETHEPTENE MUCATE

Compoziție:

ISOMETHEPTENE MUCATE 65 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

ISOMETHEPTENE-DICHLORAL-APAP ORAL- ISOMETHEPTENE MUCATE,
DICHLORALPHENAZONE,
AND ACETAMINOPHEN CAPSULE
METHOD PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ISOMETHEPTENE-DICHLORAL-APAP ORAL CAPSULES, USP
ISOMETHEPTENE-DICHLORAL-APAP
ORAL CAPSULES, USP
Rx only
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
a person takes:
More than 4,000 mg of acetaminophen in 24 hours
With other drugs containing acetaminophen
With 3 or more alcoholic drinks everyday while using this product.
DES CRIPTION
Each red capsule contains:
Isometheptene Mucate, USP 65 mg
Dichloralphenazone, USP 100 mg
Acetaminophen, USP 325 mg
Isometheptene Mucate is a white crystalline powder having a
characteristic aromatic odor and bitter
taste. It is an unsaturated aliphatic amine with sympathomimetic
properties. Its molecular weight is
492.65 and it has the following structural formula:
Acetaminophen, a non-salicylate, occurs as a white, odorless,
crystalline powder, possessing a slightly
bitter taste. Its molecular weight is 151.16 and it has the following
structural formula:
Dichloralphenazone is a white, microcrystalline powder, with slight
odor and tastes saline at first,
becoming acrid. It is a mild sedative. Its molecular weight is 519.07
and it has the following structural
formula:
The inactive ingredients are: FD&C Blue #1, Gelatin, Magnesium
Stearate, FD&C Red #40, Colloidal
Silicon Dioxide, Talc, Titanium Dioxide.
CLINICAL PHARMACOLOGY
Isometheptene Mucate, a sympathomimetic amine, acts by constricting
dilated cranial and cerebral
arterioles, thus reducing the stimuli that lead to vascular headaches.
Dichloralphenazone, a mild
sedative, reduces the patient’s emotional reaction to the pain of
both vascular and tension headaches.
Acetaminophen raises the threshold to painful stimuli, thus exerting
an analgesic effect against all types