OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

  • 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient in EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS See side panel

NDC 30142-591-08

Kroger®

Extra Strength

Acetaminophen
500 mg

Pain Reliever/Fever Reducer
Contains No Aspirin

actual size

24 RAPID RELEASE GELCAPS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

QUALITY GUARANTEE
800-632-6900
www.kroger.com

*Tylenol® is a registered trademark of Johnson & Johnson Corporation, New Brunswick, NJ 08933. Johnson & Johnson Corporation is not affiliated with The Kroger Co. or this product.

50844 ORG041751908

Kroger 44-519
(click image for full-size original)

Kroger 44-519

ACETAMINOPHEN
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-591
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color red, blue Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-591-08 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-591-08)
2 NDC:30142-591-20 1 BOTTLE in 1 CARTON contains a BOTTLE
2 225 TABLET in 1 BOTTLE This package is contained within the CARTON (30142-591-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/05/2019
Labeler — Kroger Company (006999528)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (30142-591)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (30142-591), pack (30142-591)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (30142-591)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (30142-591)

Revised: 07/2021 Kroger Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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