HYOSCYAMINE SULFATE elixir HYOSCYAMINE SULFATE solution HYOSCYAMINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chartwell RX, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinson

Product summary:

Hyoscyamine Sulfate Oral Drops (hyoscyamine sulfate oral solution, USP) (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, lemon flavored, and contains 5% ethyl alcohol. It is supplied in a 20 mL bottle (NDC 62135-513-52). Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, lemon flavored, and contains 20% ethyl alcohol. It is supplied in a pint (473 mL) bottle (NDC 62135-511-47). Hyoscyamine Sulfate Tablets, USP , 0.125 mg are white to off white, round tablets debossed with “CE” on one side and “116” on the other. Bottles of 120 NDC 62135-512-12 Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 11/2022 L70981

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE ELIXIR
HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE SOLUTION
HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET
CHARTWELL RX, 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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HYOSCYAMINE SULFATE ELIXIR, USP
HYOSCYAMINE SULFATE ORAL DROPS (HYOSCYAMINE SULFATE ORAL SOLUTION,
USP)
HYOSCYAMINE SULFATE TABLETS, USP
RX ONLY
DESCRIPTION
HYOSCYAMINE SULFATE ORAL DROPS (Hyoscyamine Sulfate Oral Solution,
USP) contains 0.125 mg
hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral
administration.
HYOSCYAMINE SULFATE ELIXIR, USP (Hyoscyamine Sulfate Elixir) contains
0.125 mg hyoscyamine sulfate per 5
mL with 20% v/v ethyl alcohol for oral administration.
HYOSCYAMINE SULFATE TABLETS, USP contain 0.125 mg hyoscyamine sulfate
formulated for oral
administration.
Hyoscyamine sulfate is one of the principal
anticholinergic/antispasmodic components of belladonna alkaloids.
The empirical formula is (C
H
NO
)
• H
SO
• 2H
O and the molecular weight is 712.85. Chemically, it
is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo
[3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate
(2:1), dihydrate with the following structure:
HYOSCYAMINE SULFATE ORAL DROPS also contain as inactive ingredients:
Ethyl alcohol, citric acid, FD&C red
#40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium
citrate, sorbitol solution, sucrose, and
water.
HYOSCYAMINE SULFATE ELIXIR also contains as inactive ingredients:
Ethyl alcohol, citric acid, FD&C red #40,
FD&C yellow #6, lemon flavor, glycerin, purified water, sodium
benzoate, sodium citrate, sorbitol solution, and
sucrose.
HYOSCYAMINE SULFATE TABLETS also contain as inactive ingredients:
Colloidal silicon dioxide, crospovidone,
magnesium stearate and microcrystalline cellulose.
CLINICAL PHARMACOLOGY
Hyoscyamine Sulfate inhibits specifically the actions of acetylcholine
on structures innerv