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Extra Strength Pain Reliever by FRED'S, INC.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: FRED'S, INC.
NDC Code: 55315-531

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.

Freds 44-531

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.  The maximum daily dose of this product is 6 tablets (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 

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. 

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 ore 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.

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 (1-8000-222-1222) 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 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage 

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

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

Principal display panel

FRED'S®

Extra Strength Non-Aspirin
Pain Reliever
Pain Reliever/Fever Reducer

Acetaminophen
EZ Tabs
100 Tablets - 500 mg each

Tested Against The Active Ingredient In:
Extra Strength TYLENOL®  EZ TABS

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

50844        REV0213D53112

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

Fred's 44-531

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-531
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-531-571 BOTTLE (1 BOTTLE) in 1 CARTON
1125 TABLET (125 TABLET) in 1 BOTTLE
2NDC:55315-531-121 BOTTLE (1 BOTTLE) in 1 CARTON
2100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-531)

Revised: 07/2013
 
FRED'S, INC.

← See all Extra Strength Pain Reliever brands

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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