Symax 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 and older: Oral or sublingual, 1 to 2 tablets 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

Symax ^® -SL is supplied as green, round, sublingual, peppermint flavored tablets debossed “SL” over “125”. Available in bottles of 100 tablets, NDC 64543-111-01.

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.

Manufactured for:
Capellon Pharmaceuticals, LLC
Ft. Worth, TX 76118

Rx Only

Rev. 06/2014

500010-02

PRINCIPAL DISPLAY PANEL

SYMAX SL hyoscyamine sulfate tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64543-111 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 SL;125 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64543-111-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/1996

Labeler — Capellon Pharmaceuticals, LLC (124568093)

Revised: 09/2021 Capellon Pharmaceuticals, LLC