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Pain Relief Extra Strength by Kmart Corporation

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Kmart Corporation
NDC Code: 49738-519

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.

Smart Sense 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • headache
    • muscular aches
    • toothache
    • backache
    • the common cold
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (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

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

  • skin reddening
  • blisters
  • rash

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

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 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
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

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

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

Questions or comments?

1-800-842-7886

Principal Display Panel

smart
sense®

NDC 49738-519-15

*COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®

EXTRA STRENGTH

pain relief

Acetaminophen
PAIN RELIEVER/FEVER REDUCER

ACTUAL SIZE

50 GELCAPS     RAPID RELEASE                   500 mg Each

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844      ORG061551915

SATISFACTION GUARANTEE
Thank you for purchasing this quality product.
If you are unsatisfied for any reason, return the unused portion to the store for a full refund or call 1-800-842-7886.

Distributed by: Kmart Corporation
Hoffman Estates, IL 60179
Shop  kmart.com 

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

Smart Sense 44-519


PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
STARCH, CORN 
SHELLAC 
Product Characteristics
ColorRED, BLUEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:49738-519-062 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
2NDC:49738-519-081 BOTTLE in 1 CARTON
224 TABLET in 1 BOTTLE
3NDC:49738-519-151 BOTTLE in 1 CARTON
350 TABLET in 1 BOTTLE
4NDC:49738-519-121 BOTTLE in 1 CARTON
4100 TABLET in 1 BOTTLE
5NDC:49738-519-54375 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/200402/28/2021
Labeler - Kmart Corporation (008965873)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49738-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(49738-519), PACK(49738-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49738-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49738-519)

 
Kmart Corporation

← See all Pain Relief Extra Strength brands

Medically reviewed on May 30, 2018

Further information

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

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