NITRO-TIME- nitroglycerin capsule

NITRO-TIME by

Drug Labeling and Warnings

NITRO-TIME by is a Prescription medication manufactured, distributed, or labeled by TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NITROGLYCERIN 6.5 MG 100 COUNT

NITROGLYCERIN 9.0 MG 100 COUNT

INGREDIENTS AND APPEARANCE

NITRO-TIME 
nitroglycerin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49483-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
WHITE WAX (UNII: 7G1J5DA97F)

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	Marketing Start Date	Marketing End Date
1	NDC: 49483-221-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018
2	NDC: 49483-221-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	6.5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)

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	Marketing Start Date	Marketing End Date
1	NDC: 49483-222-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018
2	NDC: 49483-222-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	9 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)

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	Marketing Start Date	Marketing End Date
1	NDC: 49483-223-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018
2	NDC: 49483-223-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2018

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	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-221, 49483-222, 49483-223)