NITRO-TIME

NITRO-TIME- nitroglycerin capsule
TIME CAP LABORATORIES, INC

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

HOW SUPPLIED

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

HOW SUPPLIED

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

NITROGLYCERIN 2.5 MG 100 COUNT LABEL

2.5 MG 100 COUNT
(click image for full-size original)

NITROGLYCERIN 6.5 MG 100 COUNT

6.5MG  100 COUNT
(click image for full-size original)

NITROGLYCERIN 9.0 MG 100 COUNT

9.0 MG 100 COUNT
(click image for full-size original)

NITRO-TIME
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:49483-221-06 60 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:49483-221-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
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 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 Multilevel Packaging
1 NDC:49483-222-06 60 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:49483-222-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
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 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 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 Multilevel Packaging
1 NDC:49483-223-06 60 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:49483-223-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
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), manufacture (49483-222), manufacture (49483-223)

Revised: 10/2018 TIME CAP LABORATORIES, INC

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