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Acetaminophen by Kareway Product, Inc.

Medically reviewed on Aug 2, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0153

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.

Drug Facts

Active Ingredients (in each tablet)


Acetaminophen 500mg


Purpose

Pain Reliever/fever reducer

Warnings


Liver Warning:

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

  • more than 8 tablets in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

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

These could be sign of a serious condition

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

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Overdose warning:

Taking more than the recommended dose(overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  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 4 to 6 house as needed
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor


children under 12 years
do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information
  • do not use if imprinted safety seal under cap is broken or missing.
  • Store at 15° - 30°C (59° - 86°F)
  • see end panel for lot number and expiration date

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • mentrual cramps
  • temporarily reduces fever

Package label

Non-Aspirin Pain Relief Extra Strength 40 caplates

Package Label

Non-Aspirin Pain Relief Extra Strength 40 tablets

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0153
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ICODEXTRIN 
STARCH, CORN 
SODIUM LAURYL SULFATE 
HYDROXYPROPYL CELLULOSE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorImprint CodeA500
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0153-61 BOTTLE (BOTTLE) in 1 BOX
150 TABLET (CAPSULE) in 1 BOTTLE
2NDC:67510-0153-41 BOTTLE (BOTTLE) in 1 BOX
240 TABLET (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/11/2011
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0152
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ICODEXTRIN 
STARCH, CORN 
LAURYL SULFATE 
HYDROXYPROPYL CELLULOSE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeA500
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0152-71 BOTTLE (BOTTLE) in 1 BOX
140 TABLET (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/11/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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