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Nitro-Time

Generic Name: nitroglycerin
Dosage Form: extended-release capsules

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

HOW SUPPLIED:

2.5 mg Nitroglycerin Extended-Release (Pink and Clear Capsules imprinted TCL-1221) in bottles of 60's & 100's

PACKAGE LABEL

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How is Nitro-Time Supplied

6.5 mg Nitroglycerin Extended-Release Capsules Blue/Yellow imprinted TCL1222 in bottles of 60's and 100's

PACKAGE LABEL

HOW SUPPLIED

9.0 mg Nitroglycerin Extended Release Capsules Green/Yellow imprinted TCL1223 in bottles of 60's and 100's

PACKAGE LABEL

Nitro-Time 
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-221
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
D&C RED NO. 28  
D&C YELLOW NO. 10  
ETHYLCELLULOSES  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
FERROSOFERRIC OXIDE  
LACTOSE MONOHYDRATE  
PROPYLENE GLYCOL  
SHELLAC  
SUCROSE  
TALC  
WHITE WAX  
Product Characteristics
Color pink (pink) , white (clear) Score no score
Shape capsule (CAPSULE) Size 7mm
Flavor Imprint Code TCL;1221
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-221-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-221-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Nitro-Time 
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-222
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 6.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
D&C RED NO. 33  
D&C YELLOW NO. 10  
ETHYLCELLULOSES  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
GELATIN  
LACTOSE MONOHYDRATE  
PROPYLENE GLYCOL  
SHELLAC  
DIMETHICONE  
SILICON DIOXIDE  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
WHITE WAX  
Product Characteristics
Color blue (BLUE) , yellow (YELLOW) Score no score
Shape capsule (CAPSULE) Size 8mm
Flavor Imprint Code TCL;1222
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-222-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-222-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Nitro-Time 
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-223
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 9.0 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
D&C YELLOW NO. 10  
ETHYLCELLULOSES  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C GREEN NO. 3  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GELATIN  
FERROSOFERRIC OXIDE  
LACTOSE MONOHYDRATE  
PROPYLENE GLYCOL  
SHELLAC  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
WHITE WAX  
Product Characteristics
Color green (GREEN) , yellow (YELLOW) Score no score
Shape capsule (CAPSULE) Size 9mm
Flavor Imprint Code TCL;1223
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-223-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-223-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
TIME CAP LABORATORIES, INC 037052099 manufacture(49483-221, 49483-222, 49483-223)
Revised: 06/2014
 
TIME CAP LABORATORIES, INC



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