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Extra Strength Pain Reliever by Walgreen Company

Medically reviewed on May 2, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Walgreen Company
NDC Code: 0363-0531

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.

Walgreens 44-531A

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • the common cold
    • backache
    • muscular aches
    • minor pain of arthritis
    • 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 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)
  • see end flap for expiration date and lot number 

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

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0531-15

EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg /
Pain Reliever / Fever Reducer
• Easy to swallow

50
TABLETS

Actual Size

Compare to Extra Strength Tylenol® active ingredientǂǂ

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

ǂWalgreens Pharmacist Survey Study, November 2014.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844    REV0816C53115

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.

Walgreens 44-531

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0531
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
STARCH, CORN 
TITANIUM DIOXIDE 
POVIDONE 
D&C YELLOW NO. 10 
STEARIC ACID 
SUCRALOSE 
TALC 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0531-151 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:0363-0531-121 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:0363-0531-371 BOTTLE in 1 CARTON
375 TABLET, COATED in 1 BOTTLE
4NDC:0363-0531-29150 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0363-0531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0531)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(0363-0531)

Document Id: 55ed9501-11d9-4c11-8a81-5693fd8a4eb7
Set id: b8b55b5f-4caf-4817-be92-275e1aba0cac
Version: 9
Effective Time: 20180502
 
Walgreen Company

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