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Tension Headache Relief by Walgreen Company

Medically reviewed on Feb 14, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: Walgreen Company
NDC Code: 0363-0572

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 44-572

Active ingredients (in each gelcap)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches 

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 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.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. 

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

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
  • new symptoms appear
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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 use more than directed
  • adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
  • children under 12 years: ask a doctor

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

Inactive ingredients

corn starch, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide 



Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0572-31

Tension
Headache
Relief
Acetaminophen
/ Caffeine /
Pain Reliever
• Aspirin free

80 GELCAPS
QUICK GELS™

Actual Size 

Compare to Excedrin® Tension
Headache active ingredientsǂǂ

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

ǂWalgreens Pharmacist Survey Study,
November 2016.

ǂǂThis product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache.

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

50844 REV0417B57231

44-572

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0572
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
TITANIUM DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
SHELLAC 
STEARIC ACID 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;2
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0572-311 BOTTLE in 1 CARTON
180 TABLET in 1 BOTTLE
2NDC:0363-0572-091 BOTTLE in 1 CARTON
220 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/09/2009
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0363-0572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0363-0572)

 
Walgreen Company

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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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