ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
EQUATE (Walmart Stores, 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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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning:  This product contains acetaminophen. 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 ever day while using this product

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.

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

  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other information

  • store between 20-25°C (68-77°F)

Inactive ingredients

corn starch*, crospovidone*, hypromellose, maltodextrin*, mineral oil*, polydextrose*, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triglycerides*

*contains one or more of these ingredients

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Tylenol® Extra Strength Active Ingredient†

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Contains No Aspirin

500 mg CAPLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed By: Wal-Mart Stores, Inc.

Bentonville, AR 72716

Product Label

Acetaminophen 500 mg

Equate Extra Strength Acetaminophen Caplet

 

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-158
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
HYPROMELLOSES 
MALTODEXTRIN 
MINERAL OIL 
POLYDEXTROSE 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
C10-18 TRIGLYCERIDES 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code TCL341;AV;0821
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-158-001 in 1 BOX
1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/30/2013
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)

Revised: 10/2013
Document Id: 11ee2c75-db93-4027-893f-97e1b95bcfab
Set id: bd762031-7099-46f6-8c9b-f26ab8469577
Version: 1
Effective Time: 20131001
 
EQUATE (Walmart Stores, Inc.)