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Pain Reliever Extra Strength by Harmon Store Inc.

Medically reviewed on March 19, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Harmon Store Inc.
NDC Code: 63940-975

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 44-175

Active ingredient (in each caplet)     

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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:

  • 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 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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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)
  • use by expiration date on package 

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid 

Questions or comments?

1-800-426-9391 

Principal Display Panel

CORE VALUES™

Compare to active
ingredient in Tylenol®
Extra Strength

NDC 63940-975-12

Extra Strength
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer

Actual Size

100 caplets

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

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

50844     ORG071517512

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 44-175

 

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-975
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
HYPROMELLOSE, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;175
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-975-151 BOTTLE in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE
2NDC:63940-975-121 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:63940-975-191 BOTTLE in 1 PACKAGE
38 TABLET, FILM COATED in 1 BOTTLE
4NDC:63940-975-06200 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/1993
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-975)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(63940-975), PACK(63940-975)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63940-975)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-975)

 
Harmon Store 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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