Hyoscyamine (Hyoscyamine Sulfate) - Indications and Dosage

INDICATIONS AND USAGE

Hyoscyamine Sulfate Extended-Release Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They 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). Hyoscyamine Sulfate Extended-Release Tablets, USP 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.

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, USP 0.375 mg are white, capsule-shaped tablets. They are coded "AP" on one side and "115" on the other.

Bottles of 100 tablets        NDC 50532-115-10

Store at controlled room temperature 20°-25°C (68°-77°F); excursions 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

Also available as:

	Dosage	Package	NDC
	Strength	Size
Hyoscyamine Sulfate
Tablets, USP	0.125 mg	100	50532-112-10
Hyoscyamine Sulfate
Sublingual Tablets, USP	0.125 mg	100	50532-113-10

Manufactured for:
Franklin Pharmaceutical LLC
200 North Cobb Parkway
Bldg. 400, Suite 428
Marietta, GA 30062
1-800-333-7343
www.franklinpharm.com

Ref CL5-115-00-01-0110        Rev. 01/10
5-115-00-01-0110

Printed in USA

70008012