7T GUMMY ES- acetaminophen tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

7T Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

7T Gummy ES is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

Product summary:

7T Gummy ES is supplied in the following dosage form: Eight (8) chewable gels per container Made in USA Rx Only Manufactured for: 7T Pharma, LLC 220 Emerald Vista Way Las Vegas, NV 89144 800.941.2848 NDC: 70645-500-88 Size: 8 Chewable Gels

Authorization status:

unapproved drug other

Summary of Product characteristics

7T GUMMY ES- ACETAMINOPHEN TABLET, CHEWABLE
7T PHARMA 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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7T GUMMY ES
7T GUMMY ES (ACETAMINOPHEN CHEWABLE GELS 500 MG)
7T PHARMA, LLC
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DESCRIPTION
7T Gummy ES is available as a chewable gel or gummy oral dosage form
with improved organoleptic
properties of taste, softness, chewiness, hardness, and translucency.
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:
In addition, each chewable gel contains the following inactive
ingredients: hydroxypropyl betadex,
seaweed extract (carrageenan), maltitol solution, sugar, sodium
citrate, sodium chloride, sucralose,
neotame, maltodextrin, glucose syrup, flavor, purified water.
CLINICAL PHARMACOLOGY
MECHANISM OR ACTION
The precise mechanism of the analgesic properties of acetaminophen is
not established but is thought to
involve central nervous system actions.
PHARMACODYNAMICS
Therapeutic doses of acetaminophen have negligible effects on the
cardiovascular or respiratory
systems; however, toxic doses may cause circulatory failure and rapid,
shallow breathing.
PHARMACOKINETICS
Acetaminophen is rapidly absorbed from the gastrointestinal tract and
is distributed throughout most
body tissues. A small fraction (10 to 25%) of acetaminophen is bound
to plasma proteins. 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. Acetaminophen is primarily metabolized in
the liver by first-order kinetics and
involves three principal separate pathways: conjugation with
glucuronide; conjugation with sulfate; and
oxidation via the cytochrome, P450-dependent, mixed-fu