Hyoscyamine Sulfate TAB (Page 2 of 2)

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 orally 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.

HOW SUPPLIED

Hyoscyamine Sulfate TAB is supplied as round, green, peppermint flavored tablets with “40” debossed on one side. They are available in bottles of 100 tablets, NDC 42192-340-01.

Storage and Handling

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.

Distributed by:

Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802

Rev. 07/2017
500427-06

PRINCIPAL DISPLAY PANEL

HYOSCYAMINE SULFATE TAB hyoscyamine sulfate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-340 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 D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARIC ACID

Product Characteristics Color green Score no score Shape ROUND Size 6mm Flavor PEPPERMINT Imprint Code 40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42192-340-01 100 TABLET in 1 BOTTLE None 2 NDC:42192-340-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/19/2011

Labeler — Acella Pharmaceuticals, LLC (825380939)

Revised: 09/2021 Acella Pharmaceuticals, LLC