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Headache Relief Extra Strength

Medically reviewed on May 18, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Walgreen Company
NDC Code: 0363-0751

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 44-571

Active ingredients (in each gelcap)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses
  • temporarily relieves minor aches and pains due to:
  • toothache
  • muscular aches
  • a cold
  • headache
  • arthritis
  • premenstrual and menstrual cramps

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • shock
  • facial swelling
  • hives
  • asthma (wheezing)

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.

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

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • more than 4,000 mg in 24 hours, which is the maximum daily amount

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take more or for a longer time than directed

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 have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer

Ask a doctor before use if
  • you have liver disease
  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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
  • drink a full glass of water with each dose
  • adults and children 12 years and over
  • take 2 gelcaps every 6 hours
  • do not take more than 8 gelcaps in 24 hours
  • children under 12 years: ask a doctor

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

Inactive ingredients

corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED

NDC 0363-0751-32

EXTRA STRENGTH
Headache
Relief

Acetaminophen / Aspirin (NSAID) / Caffeine /
Pain Reliever / Pain Reliever Aid

80
GELCAPS
QUICK GELS™ 

Compare to Excedrin® Extra Strength
active ingredients‡‡

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 Novartis
AG, owner of the registered trademark Excedrin® Extra Strength.

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

50844     REV0117B57131

Walgreens 44-571

HEADACHE RELIEF  EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0751
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
STARCH, CORN 
HYPROMELLOSE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
STEARIC ACID 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorGREEN (opaque) Scoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;1
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0751-321 BOTTLE in 1 CARTON
1120 TABLET in 1 BOTTLE
2NDC:0363-0751-311 BOTTLE in 1 CARTON
280 TABLET in 1 BOTTLE
3NDC:0363-0751-091 BOTTLE in 1 CARTON
320 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/09/2009
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0751)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0751)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0751)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0363-0751)

 
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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