PAIN RELIEVER EXTRA STRENGTH- 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 Pharmacy 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

  • new symptoms occur  
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • 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

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

fred's
Pharmacy

NDC 55315-519-12

EXTRA STRENGTH
PAIN RELIEVER
ACETAMINOPHEN
, 500 mg
Pain Reliever/Fever Reducer

100 GELCAPS

ACTUAL SIZE
RAPID RELEASE

Compare To The Active Ingredient in
Extra Strength TYLENOL® Rapid Release Gels*

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.  
50844      REV0417F51912

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100%
satisfaction
guaranteed

Questions or comments:
1-855-331-FRED (3733)

Freds 44-519

Freds 44-519

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-519
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
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 YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
Color RED, BLUE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L;5
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-519-15 1 in 1 CARTON 05/10/2004
1 50 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:55315-519-12 1 in 1 CARTON 05/10/2004
2 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/10/2004
Labeler - FRED'S, INC. (005866116)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(55315-519)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(55315-519)

Revised: 5/2017
Document Id: 2654de26-50b5-4389-ad11-08ae226cacb4
Set id: 70aeae91-7121-48b6-b157-1d5207a1b18c
Version: 8
Effective Time: 20170522
 
FRED'S, INC.