United States - English - NLM (National Library of Medicine)
HYOSCYAMINE SULFATE- hyoscyamine sulfate tablet
Bryant Ranch Prepack
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.
Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg
Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated
for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate
within seconds after placement on the tongue, allowing them to be swallowed with or without water.
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:
Each tablet also contains as inactive ingredients: corn starch, lactose monohydrate, magnesium stearate,
mannitol, stearic acid, and FD&C blue #1, and D&C yellow #10.
Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by
postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack
cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector
cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node and the
exocrine glands. At therapeutic doses, it is completely devoid of any action on the autonomic ganglia.
Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion.
Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions.
HHyoscyamine sulfate is absorbed totally and completely by oral administration. Once absorbed,
hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body.
The half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to
tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12
hours. Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain
barrier and the placental barrier.
INDICATIONS AND USAGE
Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment
of peptic ulcer. They can also be used to control gastric secretions, 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). Hyoscyamine Sulfate Orally Disintegrating
Tablets are 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 parkinsonism to
reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the
therapy of poisoning by anticholinesterase agents.
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy);
obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic
ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute
hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia
In the presence of high environmental temperature, heat prostration can occur with drug use (fever and
heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal
obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug
would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate
may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to
engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or
to perform hazardous work while taking this drug.
Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine
sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss,
hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation
and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to
48 hours after discontinuation of the drug.
Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease,
congestive heart failure, cardiac arrhythmias, hypertension and renal disease. Investigate any
tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with
caution in patients with hiatal hernia associated with reflux esophagitis.
Information for Patients:
Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred
vision. In this event, the patient should be warned not to engage in activities requiring mental alertness
such as operating a motor vehicle or other machinery or to perform hazardous work while taking this
Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke;
febrile patients or those who may be exposed to elevated environmental temperatures should use
Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is
administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines,
monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.
Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate
before meals; antacids after meals.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or
impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience
with hyoscyamine sulfate shows no demonstrable evidence of a problem.
Pregnancy-Pregnancy Category C:
Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known
whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly
Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate
are administered to a nursing woman.
Reported clinical experience has not identified differences in safety between patients aged 65 and over
and younger patients. In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug
may be greater in patients with impaired renal function. Because elderly patients are more likely to have
decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal
The following adverse reactions have been reported for hyoscyamine sulfate and for
pharmacologically similar drugs with anticholinergic/antispasmodic action. Adverse reactions may
include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations;
mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness;
weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation;
constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies;
urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion
and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased
To report SUSPECTED ADVERSE REACTIONS, contact Noble Pharmaceuticals, LLC at 1-888-514-
4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot
dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.
Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg
intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically
(tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be
managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200
mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to
paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until
effective respiratory action returns.
In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.
DOSAGE AND ADMINISTRATION
Dosage may be adjusted according to the conditions and severity of symptoms.
Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do
not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed
6 tablets in 24 hours.
NDC: 63629-1030-1 100 TABLET in a BOTTLE
Noble Pharmaceuticals, LLC
Cooper City, FL 33024
HYOSCYAMINE 0.125MG ODT TABLET # 100
hyoscyamine sulfate tablet
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 36 29 -10 30 (NDC:70 156 -10 6 )
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
HYO SCYAMINE SULFATE (UNII: F2R8 V8 2B8 4) (HYOSCYAMINE - UNII:PX44XO8 46 X)
0 .125 mg
Bryant Ranch Prepack
Stre ng th
STARCH, CO RN (UNII: O8 232NY3SJ)
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
MANNITO L (UNII: 3OWL53L36 A)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
no sco re
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:6 36 29 -10 30 -1
10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 7/0 1/20 19
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
Unappro ved drug o ther
10 /0 1/20 18
Bryant Ranch Prepack (171714327)
Ad d re s s
Busine ss Ope rations
Bryant Ranch Prepack
RELABEL(6 36 29 -10 30 )