Label: ACETAMINOPHEN tablet, extended release
- NDC Code(s): 30142-157-07, 30142-157-35
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
-
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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
- Keep out of reach of children.
- Directions
- 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)
-
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 (225 Tablet Container Label)
COMPARE TO the active ingredient of
TYLENOL® 8HR ARTHRITIS PAIN *See inside panelNDC 30142-157-35 EASY OPEN CAP
Kroger® 8 Hour
Arthritis Pain
Acetaminophen
Extended-Release actual size
Tablets USP, 650 mg 06Pain Reliever/
Fever ReducerFor the Temporary Relief 225 EXTENDED-
of Minor Arthritis Pain RELEASE TABLETSDO NOT USE WITH OTHER
MEDICINES CONTAINING THIS PACKAGE FOR HOUSEHOLDS
ACETAMINOPHEN WITHOUT YOUNG CHILDERN
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-157 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 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 19mm Flavor Imprint Code I;06 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-157-07 1 in 1 CARTON 05/25/2021 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:30142-157-35 225 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207229 05/25/2021 Labeler - KROGER COMPANY (006999528) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(30142-157) , MANUFACTURE(30142-157)