ACETAMINOPHEN - acetaminophen tablet, extended release 
KROGER COMPANY

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Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding,
ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults:

Under 18 years of age:

Other information

Inactive ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments? 
 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Container Label)

NDC 30142-157-07
Kroger®
TO OPEN PUSH DOWN, TURN CAP
8 Hour
Arthritis Pain
Acetaminophen
Extended-Release
Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN
24
EXTENDED-
RELEASE TABLETS


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



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton)

COMPARE TO the active ingredient of
TYLENOL® 8HR ARTHRITIS PAIN *See top panel
NDC 30142-157-07
Kroger®
8 Hour
TO OPEN
PUSH DOWN,
TURN CAP
Arthritis Pain
Acetaminophen Extended-
Release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN
actual size
24 EXTENDED-
RELEASE TABLETS



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



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Container Label)

COMPARE TO the active ingredient of
TYLENOL® 8HR ARTHRITIS PAIN *See inside panel

NDC 30142-157-35              EASY OPEN CAP

Kroger®           8 Hour


Arthritis Pain
Acetaminophen
Extended-Release         
    actual size
Tablets USP, 650 mg              06

Pain Reliever/
Fever Reducer

For the Temporary Relief       225 EXTENDED-
of Minor Arthritis Pain             RELEASE TABLETS

DO NOT USE WITH OTHER
MEDICINES CONTAINING      THIS PACKAGE FOR HOUSEHOLDS
ACETAMINOPHEN                   WITHOUT YOUNG CHILDERN
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Container Label)

ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-157
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (White to Off-White) Scoreno score
ShapeCAPSULE (Caplet) Size19mm
FlavorImprint Code I;06
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-157-071 in 1 CARTON05/25/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:30142-157-35225 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20722905/25/2021
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(30142-157) , MANUFACTURE(30142-157)

Revised: 1/2024
Document Id: 8b0c37f1-3eab-4db3-8dce-491beb6d9d84
Set id: b9b63c38-83e7-62d2-e053-2a95a90a5526
Version: 6
Effective Time: 20240124
 
KROGER COMPANY