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Pain Reliever Extra Strength by Harmon Store Inc.

Medically reviewed on February 13, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Harmon Store Inc.
NDC Code: 63940-519

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.

Core Values 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer 

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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:

  • rash
  • skin reddening
  • blisters

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

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
  • use by expiration date on package 

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?

1-800-426-9391

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CORE VALUES™

*Compare to active
ingredient in Extra Strength
Tylenol® Rapid Release Gels

Extra Strength
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin • Rapid Release

Actual Size

8 gelcaps

TAMPER EVIDENT: Use Only if This Blister is Intact

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844       ORG061551919

Distributed by: Liberty Procurement Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Core Values 44-519

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SHELLAC 
STEARIC ACID 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorBLUE, REDScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-519-191 BOTTLE in 1 PACKAGE
18 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63940-519)

 
Harmon Store Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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