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Pain Reliever Extra Strength by Walgreen Company

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Walgreen Company
NDC Code: 0363-0519

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 44-519

Active ingredient  (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • toothache  
    • backache 
    • minor pain of arthritis
    • 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
  • 3 or more alcoholic drinks ever day while using this product
  • with other drugs containing acetaminophen

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

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?

1-800-426-9391

Principal Display Panel

Well at
Walgreens

NDC 0363-0519-08

WALGREENS PHARMACIST RECOMMENDED‡

EXTRA STRENGTH
Pain Reliever
Acetaminophen
 
500 mg / Pain Reliever /
Fever Reducer

24
GELCAPS
Fast-Release
Quick Gels™

Compare to Extra Strength Tylenol®
Rapid Release Gels active ingredientǂǂ

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


‡Walgreens Pharmacist Survey Study, November 2016

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

50844  REV0417D51908

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com © 2017 Walgreen Co.

Walgreens 44-519

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0519
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, UNSPECIFIED 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Product Characteristics
ColorRED, BLUEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0519-081 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:0363-0519-121 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
3NDC:0363-0519-201 BOTTLE, PLASTIC in 1 CARTON
3225 TABLET in 1 BOTTLE, PLASTIC
4NDC:0363-0519-151 BOTTLE, PLASTIC in 1 CARTON
450 TABLET in 1 BOTTLE, PLASTIC
5NDC:0363-0519-191 VIAL in 1 CARTON
58 TABLET in 1 VIAL
6NDC:0363-0519-29150 TABLET in 1 BOTTLE
7NDC:0363-0519-54375 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(0363-0519), PACK(0363-0519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0363-0519)

Revised: 10/2017
 
Walgreen Company

← See all Pain Reliever Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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