NDC Code(s) : 58602-730-36, 58602-730-07, 58602-730-14, 58602-730-21, 58602-730-29, 58602-730-34, 58602-730-35, 58602-730-67, 58602-730-76, 58602-730-40, 58602-730-41, 58602-730-94, 58602-730-44, 58602-730-28
Packager : Aurohealth LLC

Category : Human OTC Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE
Product Information
Product Type Human OTC Drug Label Item Code (Source) NDC:58602-730
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape CAPSULE (Caplet) Size 19 mm
Flavor Imprint Code I;06
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58602-730-361 in 1 CARTON 11/09/2016
1250 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:58602-730-071 in 1 CARTON 08/11/2018
224 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:58602-730-141 in 1 CARTON 08/11/2018
350 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:58602-730-211 in 1 CARTON 08/11/2018
4100 in 1 BOTTLE Type 0: Not a Combination Product
5NDC:58602-730-29150 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
6NDC:58602-730-34200 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
7NDC:58602-730-35225 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
8NDC:58602-730-67290 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
9NDC:58602-730-76325 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
10NDC:58602-730-40500 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
11NDC:58602-730-411000 in 1 BOTTLE Type 0: Not a Combination Product08/11/2018
12NDC:58602-730-94100 in 1 BOTTLE Type 0: Not a Combination Product04/08/2020
13NDC:58602-730-44400 in 1 BOTTLE Type 0: Not a Combination Product01/11/2021
14NDC:58602-730-281 in 1 CARTON 29/12/2021
14225 in 1 BOTTLE Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207229 11/09/2016

LABELER - Aurohealth LLC(078728447)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(58602-730), MANUFACTURE(58602-730)

PRINCIPAL DISPLAY PANEL

AUROHEALTH
TO OPEN: 1. PUSH DOWN         NDC 58602-730-28
                   2. TURN CAP
 DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
 8 HOUR    ARTHRITIS PAIN
 Acetaminophen
Extended-Release
Tablets USP
650 mg
 Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
 225 Extended-release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)          



PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-730-28
*Compare to the Active
Ingredient in Tylenol®
8 HR Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
 8 HOUR ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
 Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
225 Extended-release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)