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Pain Relief EZ tabs Extra Strength

Medically reviewed on December 17, 2016

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: DOLGENCORP, LLC
NDC Code: 55910-531

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.

Rexall 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. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, which is the maximum 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. 

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.

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 of 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 adult extra strength 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 controlled room temperature 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

Since 1903
Rexall®

EXTRA STRENGTH
Pain Relief EZ Tabs

Acetaminophen 500 mg

PAIN RELIEVER/
FEVER REDUCER 

Easy Swallow Tablets (Sweet Coating)

SEE NEW WARNINGS INFORMATION

24 Coated Tablets

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

50844            REV1010A53108

Visit us at: Rexall.com
or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETSVILLE, TN 37072 USA

531-08

PAIN RELIEF EZ TABS  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-531
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 YELLOW NO. 6 
FD&C RED NO. 40 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-531-081 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55910-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55910-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55910-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(55910-531)

 
DOLGENCORP, LLC

Further information

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

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