Skip to Content

← See all Headache relief Extra Strength brands

Headache relief Extra Strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Western Family Foods, Inc.
NDC Code: 55312-184

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.


Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Pain reliever

Pain reliever

Pain reliever aid

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


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
  • asthma (wheezing)
  • shock

Liver warning:

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

  • more than 8 caplets 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

Stomach bleeding warning:

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • 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
  • if you have ever had an allergic reaction to 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.

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 are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are taking
  • any other drug containing an NSAID (prescription or nonprescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

Stop use and ask doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs os stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • 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
  • any new symptoms appear

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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • do not use 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; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at controlled room temperature 200 -  250 C (680 -  770 F)
  • excursions permitted to 15o C to 30o C (59o -86o F)
  • do not use if imprinted safety seal under cap is broken or missing
  • **this product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength

Inactive ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, and triglycerides.

Questions or comments?

1-503-639-6300 Monday- Friday 9AM- 5PM PST

Principal Display Panel

Extra strength headache relief

acetaminophen, aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-184
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorWHITE (White) Scoreno score
FlavorImprint Code2793
#Item CodePackage Description
1NDC:55312-184-101 BOTTLE (1 BOTTLE) in 1 BOX
1100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/19/2012
Labeler - Western Family Foods, Inc. (192166072)

Revised: 10/2012
Western Family Foods, Inc.

← See all Headache relief 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.