EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet 
FRED'S, INC.

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.

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Freds 44-531

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Uses

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:

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

Other information

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

Fred's 44-531

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-531
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;531
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-531-571 in 1 CARTON
1125 in 1 BOTTLE
2NDC:55315-531-121 in 1 CARTON
2100 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/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-531)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-531)

Revised: 7/2013
Document Id: a87eaa08-5bb4-4ee4-80a3-cafdc08b2a75
Set id: ae11dd25-c3e5-431c-a4f8-6b081a560fff
Version: 4
Effective Time: 20130724
 
FRED'S, INC.