Medicine guide

Excedrin Extra Strength Headache

250 mg + 250 mg + 65 mg · Tablet, Film Coated

  • Available without prescription
  • Central Nervous System Stimulant
Made by
R J General Corporation

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-11-17

What it is

Central Nervous System Stimulant

Used for
  • Headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
How to take it

Adults and children 12 years of age and over:: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

Full directions ↓
Do not take it if

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).

All warnings ↓
Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
3other products contain Acetaminophen, Aspirin (nsaid), Caffeine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily relieves minor aches and pains due to:

  • headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

From the official label · 2025-11-17 · DailyMed

Do not take it if

  • 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.

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

  • 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

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

  • an allergic reaction occurs.
  • Seek medical help right away. you experience any of the following signs of 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 occur These could be signs of a serious condition.

Quoted from the official label, section “OTC — Stop Use”.

Other 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: 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.
  • 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 severe 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 prescription or nonprescription NSAIDs (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 heart beat.
  • Do not use
  • Ask a doctor before use
  • if you have liver disease stomach bleeding warning applies to you
  • Ask a doctor or pharmacist before use
  • if you are taking 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 a doctor if an allergic reaction occurs.
  • Keep out of reach of children.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • If pregnant or breast-feeding, ask a health professional before use.
  • It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from 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.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

benzoic acid, carbuna wax, FD&C no.1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidine, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-800-468-7746

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made byR J General Corporation
Active substanceAcetaminophen, Aspirin (nsaid), Caffeine
Used inMuscles, joints and bones
Strength250 mg + 250 mg + 65 mg
FormTablet, Film Coated
RouteOral
Packs25 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH
NDC70264-045

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.