Pala-Tech Laboratories, Inc.
Pala-Tech CANINE Thyroid Chewable Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Pala-Tech CANINE Thyroid Chewable Tablets
Indications:
Provides thyroid replacement therapy in all conditions of inadequate production of thyroid hormones (hypothyroidism) in dogs.
Dosage:
The initial recommended dose of levothyroxine is 0.1 mg/10lb (4.5 kg) body weight twice daily. Dosage is then adjusted by monitoring the post-pill blood level of thyroid hormone in the dog every four weeks until an adequate maintenance dose is established.
Administration:
Each tablet, Pala-Tech Canine Thyroid Chewable Tablets, may be given orally to dogs as a treat, or crumbled over their food at the veterinarian-prescribed dose. If crumbled over food, consumption should be monitored.
Composition:
0.1mg
Each scored, round chewable tablet contains 0.1 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.2mg
Each scored, round chewable tablet contains 0.2 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.3mg
Each scored, round chewable tablet contains 0.3 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.4mg
Each scored, round chewable tablet contains 0.4 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.5mg
Each scored, round chewable tablet contains 0.5 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.6mg
Each scored, round chewable tablet contains 0.6 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.7mg
Each scored, round chewable tablet contains 0.7 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.8mg
Each scored, round chewable tablet contains 0.8 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
0.9mg
Each scored, round chewable tablet contains 0.9 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
1.0mg
Each scored, round chewable tablet contains 1.0 mg of Levothyroxine Sodium, USP in a proprietary, highly palatable roast beef and liver flavor base.
Precaution:
Administer with caution to animals with clinically significant heart disease, hypertension, or other complications for which a sharply increased metabolic rate might prove hazardous. Use in pregnant bitches has not been evaluated.
KEEP OUT OF REACH OF CHILDREN
Store at room temperature; 15 degrees C - 30 degrees C (59 degrees F - 86 degrees F) and protect from light. Dispense product in this container or another tight, light-resistant container as defined in the USP.
CAUTION:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Pala-Tech CANINE Thyroid Chewable Tablets 0.1mg 180 Tablets
Pala-Tech CANINE
Thyroid Chewable Tablets 0.1mg 1000 Tablets
Pala-Tech CANINE Thyroid
Chewable Tablets 0.2mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets
0.2mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.3mg 180
Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.3mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.4mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.4mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.5mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.5mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.6mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.6mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.7mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.7mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.8mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.8mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.9mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 0.9mg 1000 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 1.0mg 180 Tablets
Pala-Tech CANINE Thyroid Chewable Tablets 1.0mg 1000 Tablets
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0001 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.1 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;1 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0001-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0001-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0002 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.2 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;2 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0002-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0002-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0003 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.3 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;3 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0003-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0003-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0004 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.4 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;4 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0004-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0004-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0005 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.5 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;5 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0005-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0005-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0006 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.6 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;6 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0006-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0006-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0007 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.7 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;7 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0007-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0007-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0008 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.8 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;8 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0008-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0008-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0009 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
0.9 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
0;9 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0009-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0009-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
Pala-Tech CANINE Thyroid
LEVOTHYROXINE SODIUM TABLET, CHEWABLE
Product Information
|
|
Product Type
|
Prescription animal drug label |
Item Code (Source)
|
NDC:59068-0010 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LEVOTHYROXINE SODIUM LEVOTHYROXINE |
|
1.0 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
brown (Brownish-Red) |
9 mm |
1; |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:59068-0010-0 |
180 in 1 BOTTLE |
|
|
|
2 |
NDC:59068-0010-1 |
1000 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
2013-06-20 |
|
|
