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Headache Relief Extra Strength

acetaminophen, aspirin, caffeine · Headache Relief Extra Strength is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin, caffeine, made by 11 manufacturers.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
11

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

Drug facts

Generic name
acetaminophen, aspirin, caffeine
Active ingredients
Acetaminophen, Aspirin, Caffeine
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet, Tablet, coated, Tablet, film coated
Label holder
Safeway, Inc.
FDA application
M013
Label updated
08/19/2026

Active ingredients

(in each geltab) 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 a cold arthritis muscular aches toothache premenstrual and menstrual cramps

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 geltabs every 6 hours; do not take more than 8 geltabs in 24 hours children under 12 years: do not use unless directed by a doctor

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 severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) 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 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 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. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have 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 doctor 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 more than 3 days any new symptoms occur 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

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.

Ask a doctor before use

Liver disease stomach bleeding warning applies to you you have 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

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

Stop use and ask doctor 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 more than 3 days any new symptoms occur These could be signs of a serious condition.

Pregnancy or breastfeeding

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.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information

Store between 20º-25ºC (68º-77ºF)

Inactive ingredients

Black printing ink, corn starch, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hydroxypropyl cellulose, hydroxypropyl cellulose-low substituted, hypromellose, iron oxide black, maltitol, povidone, purified water, stearic acid, talc, titanium dioxide

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Forms and strengths

From the FDA NDC Directory · 16 product codes

Dosage formStrengthRouteNDCs
Tablet250 mg / 250 mg / 65 mgoral14
Tablet, coated250 mg / 250 mg / 65 mgoral1
Tablet, film coated250 mg / 250 mg / 65 mgoral1

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $0.0633 per tablet, capsule or unit across 1 package code.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Manufacturers and labels

16 FDA labels

  • Safeway, Inc.Shown hereM013 · Label 08/19/2026 · NDC 21130-586Full label
  • CVS PharmacyM013 · Label 07/14/2025 · NDC 69842-586Full label
  • Cardinal Health 110, LLC. DBA LeaderM013 · Label 07/13/2026 · NDC 70000-0146Full label
  • Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)M013 · Label 03/18/2024 · NDC 55910-686Full label
  • EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)M013 · Label 03/25/2026 · NDC 49035-786Full label
  • Family Dollar (FAMILY WELLNESS)M013 · Label 03/27/2024 · NDC 55319-511Full label
  • H E BM013 · Label 04/09/2024 · NDC 37808-586Full label
  • P & L Development, LLCM013 · Label 06/12/2026 · NDC 59726-586Full label
  • P & L Development, LLCM013 · Label 08/06/2025 · NDC 59726-011Full label
  • TARGET CorporationM013 · Label 06/06/2024 · NDC 11673-686Full label
  • The Kroger Co.M013 · Label 06/10/2024 · NDC 30142-865Full label
  • The Kroger Co.M013 · Label 06/10/2024 · NDC 30142-586Full label
  • The Kroger Co.M013 · Label 06/07/2024 · NDC 30142-625Full label
  • WalgreensM013 · Label 10/07/2025 · NDC 0363-0586Full label
  • WalgreensM013 · Label 07/10/2024 · NDC 0363-1150Full label
  • WalgreensM013 · Label 07/10/2024 · NDC 0363-0865Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Headache Relief Extra Strength: common questions

What is Headache Relief Extra Strength used for?
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Is Headache Relief Extra Strength a prescription drug?
No. Headache Relief Extra Strength is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Headache Relief Extra Strength?
Yes. Other FDA-listed products with the same active ingredients include Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength, Migraine Relief.
Who makes Headache Relief Extra Strength?
11 manufacturers list Headache Relief Extra Strength with the FDA, including Safeway, Inc., CVS Pharmacy, Cardinal Health 110, LLC. DBA Leader.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/19/2026 · Label text is shown as published by the manufacturer. Not medical advice