Hyoscyamine Sulfate Extended-Release (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.

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 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.

HOW SUPPLIED

Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, capsule shaped, biconvex tablets debossed with “CL” on one side and “14” on the other.

Bottles of 180
NDC 33261-0907-99

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

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

KEEP OUT OF REACH OF CHILDREN

Manufactured for:

County Line Pharmaceuticals, LLC
Brookfield, WI 53005

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

For inquiries call toll free 1-866-207-5636.

PI-9328
Rev 02/09

PRINCIPAL DISPLAY PANEL

IMAGE LABEL
(click image for full-size original)

NDC 33261-0907-99

180 Tablets

Hyoscyamine Sulfate Extended-Release Tablets

0.375 mg

Rx Only

Each tablet contains 0.375 mg hyoscyamine sulfate, USP.

USUAL DOSAGE: See package insert for full prescribing information.

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

Store at controlled room temperature 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F). Please refer to the current USP.

HYOSCYAMINE SULFATE EXTENDED-RELEASE
hyoscyamine sulfate extended-release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-907(NDC:43199-014)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.375 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code CL;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-907-99 180 TABLET (180 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/03/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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