Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
■ 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 ■ do not take more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor
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
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and 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 ■ 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 8 caplets in 24 hours, which is the maximum daily amount ■ 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.
■ 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.
■ 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
■ taking a prescription drug for diabetes, gout, or arthritis
■ taking any other drug or are under a doctor’s care for any serious condition
■ 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 loss of hearing occurs
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ painful area is red or swollen
■ any new symptoms appear.
These could be signs of a serious condition.
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.
■ 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
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor
■ Store in a dry place at 15° – 30°C (59° – 86°F)
■ use by expiration date on package
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
1-800-231-4670
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†CVS™ is not affiliated with the owner of the registered trademark Excedrin® Extra Strength Headache.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
VALUE SIZE
CVS™
NDC 69842-541-17
Extra Strength HEADACHE RELIEF
Acetaminophen, 250 mg
Aspirin (NSAID), 250 mg
Caffeine, 65 mg
Pain Reliever, Pain Reliever Aid
Compare to Excedrin® Extra Strength Headache active ingredients†
300 CAPLETS
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | ITF | 7725 | 5004-300C-CVS-A2_LBL R53475_966960_Headache Relief ES.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-541-01 | Acetaminophen, Aspirin, Caffeine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 6 | |
| 69842-541-01 | Acetaminophen, Aspirin, Caffeine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 69842-541-06 | Acetaminophen, Aspirin, Caffeine | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | 6 | |
| 69842-541-16 | Acetaminophen, Aspirin, Caffeine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 69842-541-16 | Acetaminophen, Aspirin, Caffeine | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 6 | |
| 69842-541-17 | Acetaminophen, Aspirin, Caffeine | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-541 | 69842-541-06, 69842-541-17, 69842-541-01, 69842-541-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-05-08 | full-release | 2026-06-01 00:12:14 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | CVS Pharmacy, Inc. | 6deb854f-863e-24ad-e053-2991aa0afb17 | 2025-10-21 | Warnings | 69842-541-16 69842-541-06 69842-541-01 69842-541-17 69842-541 69842054106 69842054101 69842054116 69842054117 41adc9d6-b54a-c80b-e063-6294a90af593 6deb854f-863e-24ad-e053-2991aa0afb17 |
Adverse event summaries are temporarily unavailable. Other product information remains available.