DOSAGE AND ADMINISTRATION
Dosage may be adjusted according to the condition and severity of symptoms. May be taken with or without water.
Adults and adolescents 12 years of age and older: 1 to 2 tablets sublingually three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage may be increased to every four hours as needed. Do not exceed 12 tablets in 24 hours.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
Hyoscyamine Sulfate SL is supplied as round, green, peppermint flavored tablets with “39” debossed on one side. They are available in bottles of 100 tablets, NDC 42192-339-01.
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.
Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
PRINCIPAL DISPLAY PANEL
| HYOSCYAMINE SULFATE SL |
hyoscyamine sulfate tablet
|Labeler — Acella Pharmaceuticals, LLC (825380939)|
Revised: 09/2021 Acella Pharmaceuticals, LLC
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