Hyoscyamine Sulfate SL (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 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.

HOW SUPPLIED

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.

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
500426-06

PRINCIPAL DISPLAY PANEL

Bottle label
(click image for full-size original)

HYOSCYAMINE SULFATE SL
hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-339
Route of Administration SUBLINGUAL 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 39
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-339-01 100 TABLET in 1 BOTTLE None
2 NDC:42192-339-05 500 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: 11/2019 Acella Pharmaceuticals, LLC

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