Hyoscyamine Sulfate (Page 2 of 2)

ADVERSE REACTIONS

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 sweating.

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.

OVERDOSAGE

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.

HOW SUPPLIED

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg are light blue, round, biconvex tablets, debossed with “N” on one side and “105” on the other.

Bottles of 100
NDC 70156-105-01

Store at controlled room temperature 20C°-25°C (68F°-77°F); excursion permitted to 15C°-30°C (59F°-86°F) see USP controlled room temperature.

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Marketed by:

Noble Pharmaceuticals, LLC
Cooper City, FL 33024

Iss. 09/18

PRINCIPAL DISPLAY PANEL

NDC 70156-105-01

Hyoscyamine Sulfate Sublingual Tablets

0.125 mg

Rx Only

100 Tablets

label
(click image for full-size original)
HYOSCYAMINE SULFATE
hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70156-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code N;105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70156-105-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/01/2018
Labeler — Noble Pharmaceuticals, LLC (080006461)

Revised: 03/2022 Noble Pharmaceuticals, LLC

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