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Headache Relief Extra Strength

Medically reviewed on June 8, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-433

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.

Equate 44-334B

Active ingredients (in each caplet)

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:
    • headache
    • muscular aches
    • a cold
    • arthritis
    • toothache
    • 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:

  • hives
  • facial swelling
  • shock
  • 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
  • more than 4,000 mg of acetaminophen in 24 hours
  • 3 or more alcoholic drinks every day while using this product

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

  • are age 60 or older
  • take more or for a longer time than directed
  • 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

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

  • 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 this product or any of its ingredients

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

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
  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • ringing in the ears or a loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur
  • 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. 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 take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over
    • take 2 caplets every 6 hours
    • do not take more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor 

Other information
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™ 

NDC 49035-433-85

Compare
to Excedrin®
Extra Strength
Caplets Active
Ingredients**

Extra Strength

Headache
Relief
Acetaminophen,

Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

200
CAPLETS 

Actual Size

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

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Distributed by:Wal-Mart Stores, Inc.,
Bentonville, AR 72716

**This product is not manufactured or distributed by
Novartis AG, owner of the registered trademark
Excedrin® Extra Strength Caplets.

50844    REV0418A33406

44-334B

HEADACHE RELIEF  EXTRA STRENGTH
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-433
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
STARCH, CORN 
HYPROMELLOSE, UNSPECIFIED 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
CROSPOVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;334
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-433-081 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
2NDC:49035-433-062 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:49035-433-85200 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/13/2008
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-433)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-433)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49035-433)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-433)

 
Wal-Mart Stores Inc

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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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