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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
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- 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 form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 250 mg / 250 mg / 65 mg | oral | 14 |
| Tablet, coated | 250 mg / 250 mg / 65 mg | oral | 1 |
| Tablet, film coated | 250 mg / 250 mg / 65 mg | oral | 1 |
What pharmacies pay
National Average Drug Acquisition Cost (NADAC), week of 10/21/2026
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
- Class IIDrugOngoing01/14/2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster...SpecGx, LLC · 2 products · Failed Tablet/Capsule Specification: There is a potential for the...
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
- Class IIDrugOngoing11/05/2025TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer...Kenvue Brands LLC · Defective Container
- Class IIDrugOngoing09/03/2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter...Baxter Healthcare Corporation · Discoloration
- Class IIDrugOngoing06/25/2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry...Aurobindo Pharma USA Inc · cGMP deviations: Due to confirmed consumer complaints received...
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