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Acetaminophen Extra Strength by Wal-Mart Stores Inc

Medically reviewed on March 15, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-531

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.

Equate 44-531A

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

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

Warnings

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

  • more than 4,000 mg 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

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

  • blisters
  • rash
  • skin reddening

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

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.
  • 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 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

corn starch, 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, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

 1-888-287-1915

Principal display panel

NDC 49035-531-12

equate™                                                   Compare to Extra Strength Tylenol® Active Ingredient*

Extra Strength

Acetaminophen
500 mg
Pain Reliever/Fever Reducer

•Contains no aspirin
•Easy to swallow
•Sweet coated

500 mg               100 TABLETS                       Actual Size

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

DISTRIBUTED BY:Wal-Mart Stores, Inc., Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844        ORG081653112

Equate 44-531

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-531
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
STARCH, CORN 
TITANIUM DIOXIDE 
DEXTROSE MONOHYDRATE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-531-121 BOTTLE in 1 CARTON
1100 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 - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(49035-531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49035-531)

 
Wal-Mart Stores Inc

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Further information

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

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