ALPRAZOLAM (Page 7 of 7)

ANIMAL STUDIES

When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

Manufactured by:

ALPHAPHARM PTY. LTD.

15 Garnet Street,

Carole Park. Qld. 4300

Australia

110/7 Revised October 2007

ALPRAZOLAM
alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-006
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alprazolam (Alprazolam) Alprazolam 0.25 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Corn Starch
Docusate Sodium
Povidone
Sodium Starch Glycollate
Lactose Monohydrate
Magnesium Stearate
Colloidal Silicon Dioxide
Sodium Benzoate
D&C Yellow No. 10
Product Characteristics
Color YELLOW (Pale Yellow) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code AL;0.25;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-006-02 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:57315-006-03 500 TABLET (500 TABLET) in 1 BOTTLE None
3 NDC:57315-006-04 1000 TABLET (1000 TABLET) in 1 BOTTLE None
ALPRAZOLAM
alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-007
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alprazolam (Alprazolam) Alprazolam 0.5 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Corn Starch
Docusate Sodium
Povidone
Sodium Starch Glycollate
Lactose Monohydrate
Magnesium Stearate
Colloidal Silicon Dioxide
Sodium Benzoate
FDC Yellow No. 6
DC Yellow No. 10
Product Characteristics
Color YELLOW (Dark Yellow) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code AL;0.5;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-007-04 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:57315-007-03 500 TABLET (500 TABLET) in 1 BOTTLE None
3 NDC:57315-007-02 100 TABLET (100 TABLET) in 1 BOTTLE None
ALPRAZOLAM
alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-008
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alprazolam (Alprazolam) Alprazolam 1 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Corn Starch
Docusate Sodium
Povidone
Sodium Starch Glycollate
Lactose Monohydrate
Magnesium Stearate
Colloidal Silicon Dioxide
Sodium Benzoate
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code AL;1.0;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-008-04 1000 TABLET (1000 TABLET) in 1 BOTTLE None
2 NDC:57315-008-03 500 TABLET (500 TABLET) in 1 BOTTLE None
3 NDC:57315-008-02 100 TABLET (100 TABLET) in 1 BOTTLE None
ALPRAZOLAM
alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57315-012
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alprazolam (Alprazolam) Alprazolam 2 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Corn Starch
Docusate Sodium
Povidone
Sodium Starch Glycollate
Lactose Monohydrate
Magnesium Stearate
Colloidal Silicon Dioxide
Sodium Benzoate
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code A;L;G;2
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57315-012-02 500 TABLET (500 TABLET) in 1 BOTTLE None
2 NDC:57315-012-01 100 TABLET (100 TABLET) in 1 BOTTLE None
Labeler — ALPHAPHARM PTY. LTD.

Revised: 11/2007 ALPHAPHARM PTY. LTD.

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