cetate on an empty stomach, at least one hour before or two to three hours after meals. For additional information, see PRECAUTIONS.
How is Galzin Supplied
Galzin®, Zinc Acetate Capsules (25 mg zinc content) are #1 capsules with aqua blue opaque cap and body, imprinted "93-215." Packaged in bottles of 250 (NDC 57844-215-52).
Galzin®, Zinc Acetate Capsules (50 mg zinc content) are #1 capsules with orange opaque cap and body, imprinted "93-208." Packaged in bottles of 250 (NDC 57844-208-52).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Rx only.
Manufactured For:
GATE PHARMACEUTICALS
Div. of Teva Pharmaceuticals USA
Sellersville, PA 18960
Manufactured By:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 11/2005
PRINCIPAL DISPLAY PANEL FOR NDC 57844-215-52
Galzin® (zinc acetate) capsules
25 mg
250 capsules
NDC 57844-215-52
Each aqua blue capsule contains: Zinc Acetate equivalent to 25 mg zinc
PRINCIPAL DISPLAY PANEL FOR NDC 57844-208-52
Galzin® (zinc acetate) capsules
50 mg
250 capsules
NDC 57844-208-52
Each orange capsule contains: Zinc Acetate equivalent to 50 mg zinc
Galzin
zinc acetate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57844-215
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC ACETATE (ZINC CATION) ZINC CATION 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
magnesium stearate
titanium dioxide
FD&C BLUE NO. 1
GELATIN
Product Characteristics
Color BLUE (aqua blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 93;215
Contains
Packaging
Item Code Package Description
1 NDC:57844-215-52 250 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020458 01/28/1997
Galzin
zinc acetate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57844-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC ACETATE (ZINC CATION) ZINC CATION 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
magnesium stearate
titanium dioxide
METHYLPARABEN
propylparaben
FD&C RED NO. 40
D&C RED NO. 28
D&C YELLOW NO. 10
GELATIN
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 93;208
Contains
Packaging
Item Code Package Description
1 NDC:57844-208-52 250 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Categ
