Acetaminophen by The Kroger Company / Ohm Laboratories Inc. Acetaminophen

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by The Kroger Company, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet, extended release 
The Kroger Company

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Acetaminophen

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps
  • headache
  • the common cold
• temporarily reduces fever

Warnings

Liver warning

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

• more than 6 caplets 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 haveliver disease.

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

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

• do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• children under 12 years:
  • do not use

Other information

• store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
• see end panel for batch number and expiration date
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

COMPARE TO the active ingredient of
TYLENOL ®8HR *See side panel

NDC: 30142-968-01

Kroger ®

USE ONLY AS DIRECTED

OUR PHARMACIST RECOMMENDED

8 Hour Pain Relief †

Acetaminophen
Extended-Release
Tablets USP, 650 mg
Pain Reliever/Fever Reducer

†For up to 8 Hour Relief of Minor Muscle Aches & Pain

actual
size

100 CAPLETS**
**capsule-shaped tablets

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-968
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule Shaped)	Size	19mm
Flavor		Imprint Code	cor116
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-968-01	1 in 1 CARTON	02/19/2021	12/31/2025
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076200	02/19/2021	12/31/2025

Labeler - The Kroger Company (006999528)

Registrant - Ohm Laboratories Inc. (051565745)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(30142-968)

Revised: 1/2025

Document Id: 2b963bd7-9b48-5dca-e063-6394a90a5baf

34390-5

Set id: e2b402d7-0f68-49a0-b68a-f3e359efc780

Version: 5

Effective Time: 20250113