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.
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 may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.
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.
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg are white, round, flat-faced, beveled edge, mint flavored tablets debossed with “CL” on one side and “11” on the other.
Bottles of 60
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
To report SUSPECTED ADVERSE REACTIONS, contact County Line at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of suspected adverse reactions.
County Line Pharmaceuticals, LLC
Pine Brook, NJ 07058 USA
Hyoscyamine Sulfate Sublingual Tablets
| HYOSCYAMINE SULFATE |
hyoscyamine sulfate tablet
|Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)|
|Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)|
|PD-Rx Pharmaceuticals, Inc.||156893695||repack (43063-321)|
Revised: 02/2023 PD-Rx Pharmaceuticals, Inc.
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