NDC Code(s) : 49483-341-01, 49483-341-50, 49483-341-10, 49483-341-20
Packager : TIME CAP LABS INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN ACETAMINOPHEN TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-341
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL(UNII: T5L8T28FGP)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
Product Characteristics
Color white Score no score
Shape OVAL ((caplet)) Size 17 mm
Flavor Imprint Code TCL341
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49483-341-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/12/2018
2NDC:49483-341-50500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/05/2021
3NDC:49483-341-101000 in 1 BOTTLE Type 0: Not a Combination Product20/01/2022
4NDC:49483-341-20200 in 1 BOTTLE Type 0: Not a Combination Product25/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 07/18/2011

LABELER - TIME CAP LABS INC(037052099)

REGISTRANT - TIME CAP LABS INC(037052099)

Establishment
Name Address ID/FEI Business Operations
TIME CAP LABS INC 037052099 manufacture(49483-341)

Establishment
Name Address ID/FEI Business Operations
MARKSANS PHARMA LIMITED 677604129 manufacture(49483-341)

PRINCIPAL DISPLAY PANEL

341R- Timely APAP 500mg 100ct label

341R- Timely APAP 500mg 100ct label

341R- Timely APAP 500mg 200ct label

341R- Timely APAP 500mg 100ct label

341R- Timely APAP 500mg 500ct label

341R- Timely APAP 500mg 100ct label 341R- Timely APAP 500mg 1000ct label

341R- Timely APAP 500mg 100ct label