Kroger Co. Acetaminophen Drug Facts

Kroger Co. Acetaminophen Drug Facts

Drug Labeling and Warnings

Drug Details

k">

ACETAMINOPHEN- acetaminophen tablet, film coated 
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.

----------

Kroger Co. Acetaminophen Drug Facts

Active ingredient (in each tablet)

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

  • 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 have ever had an allergic reaction to this product or any of its ingredients

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 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 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

corn starch*, croscarmellose sodium*, FD&C red #40 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of EXTRA STRENGTH TYLENOL®

SEE NEW WARNINGS

See side panel

FOR ADULTS

Acetaminophen

Pain Reliever/Fever Reducer

EXTRA STRENGTH

Sweet Coated

Easy Tabs

actual size

EASY TO SWALLOW

100 TABLETS

500 mg EACH

Acetaminophen Image
ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-340
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN (UNII: 5C69YCD2YJ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUND (convex) Size11mm
FlavorImprint Code L227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-340-781 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/11/2014
Labeler - Kroger Company (006999528)

Revised: 1/2015
 
Kroger Company


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.