Symax Duotab (Page 2 of 2)

OVERDOSAGE

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 LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and older: 1 to 2 tablets every 12 hours. Dosage may be adjusted to 1 tablet every 8 hours if needed. Do not exceed 4 tablets in 24 hours.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

Tablets should be swallowed whole.

HOW SUPPLIED

Purple and white, bilayered, capsule-shaped tablets debossed “SYMAX” on one side, “DUOTAB” on the opposite side. Bottles of 90 tablets NDC 64543-118-90, and professional physician starter packages of 1 tablet NDC 64543-118-02.

Storage and Handling

Store at controlled room temperature, 20°-25°C (68°-77°F), see USP Controlled Room Temperature.

Dispense in tight, light-resistant containers as defined in the USP/NF.

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
Fort Worth, TX 76118

Rev. 05/2016

500157-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

figure-02
(click image for full-size original)
SYMAX DUOTAB
hyoscyamine sulfate tablet, multilayer, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64543-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.375 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
D&C RED NO. 30
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSES
POVIDONE K30
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (Layer 2) , purple (Layer 1) Score no score
Shape OVAL (BILAYERED) Size 15mm
Flavor Imprint Code SYMAX;DUOTAB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64543-118-90 90 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:64543-118-02 12 POUCH in 1 CARTON contains a POUCH
2 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 POUCH This package is contained within the CARTON (64543-118-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/07/2009
Labeler — Capellon Pharmaceuticals, LLC (124568093)

Revised: 09/2021 Capellon Pharmaceuticals, LLC

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