NDC Code(s) : 0904-6720-80, 0904-6720-51, 0904-6720-59, 0904-6720-60, 0904-6720-40, 0904-6720-24
Packager : Major Pharmaceuticals

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

acetaminophenAcetaminophen TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6720
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
CARNAUBA WAX(UNII: R12CBM0EIZ)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code L484
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6720-801000 in 1 BOTTLE Type 0: Not a Combination Product26/07/2018
2NDC:0904-6720-511 in 1 CARTON 30/07/2018
250 in 1 BOTTLE Type 0: Not a Combination Product26/07/2018
3NDC:0904-6720-591 in 1 CARTON 30/07/2018
3100 in 1 BOTTLE Type 0: Not a Combination Product26/07/2018
4NDC:0904-6720-60100 in 1 BOTTLE Type 0: Not a Combination Product27/08/2018
5NDC:0904-6720-40500 in 1 BOTTLE Type 0: Not a Combination Product28/08/2018
6NDC:0904-6720-241 in 1 CARTON 28/08/2018
624 in 1 BOTTLE Type 0: Not a Combination Product28/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 07/26/2018

LABELER - Major Pharmaceuticals(191427277)

PRINCIPAL DISPLAY PANEL

MAJOR®

compare to the active ingredient in Extra Strength Tylenol® Caplets

extra strength

acetaminophen

acetaminophen 500 mg

pain reliever/fever reducer

for adults

aspirin free

500 caplets

actual size

major-acetaminophen-container-image.jpg