PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated 
DOLGENCORP, LLC

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Rexall 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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.

In case of overdose, get medical help or contact a Poison Control Center 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

Other information

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

Principal Display Panel

Since 1903
Rexall®

EXTRA STRENGTH

Pain Relief
Acetaminophen 500 mg

• Pain Reliever
• Fever reducer
• Contains no
aspirin

120
Gelcaps

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

50844       REV0322E51932

Visit us at: Rexall.com or call 1-866-4-REXALL
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
Since 1903 Rexall® is a registered trademark of Rexall Sundown, Inc.

Rexall 44-519

Rexall 44-519

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-812
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred, blueScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-812-32120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
2NDC:55910-812-081 in 1 CARTON05/10/200403/04/2022
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/10/2004
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(55910-812) , pack(55910-812)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(55910-812)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(55910-812)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(55910-812)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(55910-812)

Revised: 6/2023
Document Id: 23a1347f-f594-4201-b5ca-278109dd6213
Set id: ce9f4e0d-43fb-499a-b8a2-a997a14841c4
Version: 18
Effective Time: 20230628
 
DOLGENCORP, LLC