ED-SPAZ (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg must be placed on top of the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.

Adults and pediatric patients 12 years of age and older

1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age

½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

HOW SUPPLIED

ED-SPAZ Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white, round, flat beveled edge tablets debossed “634″ on one side and a score line on other side.

Bottles of 100 NDC 0485-0082-01

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:
Belcher Pharmaceuticals, Inc.
6911 Bryan Dairy Road
Largo, FL 33777

Manufactured for:
Edwards Pharmaceutical, Inc.
111 W. Mulberry St.
Ripley, MS 38663

May 2010
L18I
R-0510

PRINCIPAL DISPLAY PANEL — 0.125 mg Tablet Bottle Label

NDC 0485-0082-01

ED-SPAZ
Hyoscyamine Sulfate Orally
Disintegrating
Tablets

0.125 mg

100 Tablets

Rx only

PRINCIPAL DISPLAY PANEL -- 0.125 mg Tablet Bottle Label
(click image for full-size original)
ED-SPAZ
hyoscyamine sulfate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0485-0082
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
Product Characteristics
Color white Score 2 pieces
Shape ROUND (FLAT, BEVELED EDGE) Size 6mm
Flavor Imprint Code 634
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0485-0082-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/12/2010
Labeler — EDWARDS PHARMACEUTICALS, INC. (195118880)
Establishment
Name Address ID/FEI Operations
BELCHER PHARMACEUTIALS, INC. 965082543 manufacture (0485-0082), pack (0485-0082), label (0485-0082), analysis (0485-0082)

Revised: 03/2020 EDWARDS PHARMACEUTICALS, INC.

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