OSCIMIN- hyoscyamine sulfate tablet, orally disintegrating

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Διαθέσιμο από:

Larken Laboratories, Inc.

INN (Διεθνής Όνομα):

HYOSCYAMINE SULFATE

Σύνθεση:

HYOSCYAMINE SULFATE 0.125 mg

Οδός χορήγησης:

SUBLINGUAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.

Περίληψη προϊόντος:

OSCIMIN Sublingual Tablets are supplied as round, green, peppermint flavored tablets with “LL” over “253” debossed on one side. Available in bottles of 100 tablets, NDC 68047-253-01. Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY . Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 07/2021 500414-02

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

OSCIMIN - HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
LARKEN LABORATORIES, INC.
_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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OSCIMIN SUBLINGUAL TABLETS
DESCRIPTION
Each tablet for sublingual administration contains:
Hyoscyamine Sulfate, USP …… 0.125 mg.
Hyoscyamine sulfate is one of the principal
anticholinergic/antispasmodic components of belladonna alkaloids.
Hyoscyamine sulfate is Benzeneacetic acid, α-(hydroxymethyl)-, 8-
methyl-8-azabicyclo[3.2.1]oct-3-yl ester,
[3(S)-endo]-, sulfate (2:1), dihydrate.
(C
H
NO
) • H
SO • 2H
O M.W. = 712.85
INACTIVE INGREDIENTS
Inactive ingredients include: D&C Yellow #10 Aluminum Lake, FD&C Blue
#1 Aluminum Lake, lactose
monohydrate, magnesium stearate (veg), mannitol, peppermint flavor,
starch and stearic acid.
CLINICAL PHARMACOLOGY
Hyoscyamine has actions similar to those of atropine, but is more
potent in both its central and peripheral
effects.
This product inhibits gastrointestinal propulsive motility and
decreases gastric acid secretions. This product
controls excessive pharyngeal, tracheal, and bronchial secretion.
Once absorbed, this product disappears rapidly from the blood and is
distributed throughout the entire body.
The majority of hyoscyamine sulfate is excreted in the urine unchanged
within the first 12 hours and only
traces of hyoscyamine sulfate are found in the breast milk.
INDICATIONS AND USAGE
This product may be used in functional intestinal disorders to reduce
symptoms such as those seen in mild
dysenteries and diverticulitis. It can also be used to control gastric
secretion, visceral spasm and hypermotility
in cystitis, pylorospasm and associated abdominal cramps. Along with
appropriate analgesics, this product is
indicated in symptomatic relief of biliary and renal colic and as a
drying agent in the relief of symptoms of
acute rhinitis.
This product is effective as adjunctive therapy in t