Headache Relief
Acetaminophen, Aspirin, Caffeine · Tablet, Film Coated · Oral, Sublingual
Active ingredient
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Purpose
Purpose Pain reliever Pain reliever Pain reliever aid
Uses
Uses temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches toothache premenstrual and menstrual cramps
Warnings
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: Aspirin may cause a severe allergic reaction which may include: shock facial swelling hives 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 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 heart beat. Do not use if you have ever had an allergic reaction to 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 you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis Stop use and ask a 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 redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts 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 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 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
Do not use if you have ever had an allergic reaction to 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
Ask a doctor before use if you have liver disease you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis
Stop use and ask a doctor
Stop use and ask a 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 redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear
Pregnancy or breast-feeding
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions do not take 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. Do not take more than 8 caplets in 24 hours. children under 12 years: ask a doctor
Other information
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Label text from the FDA structured product label by Publix Super Markets Inc (revised Aug 21, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 39 products
- Aspirin in 39 products
- Caffeine in 39 products
- Atropa Belladonna in 2 products
- Iris Versicolor Root in 2 products
- Gelsemium Sempervirens Root in 1 product
- Ipecac in 1 product
- Cyclamen Purpurascens Tuber in 1 product
- Coffea Arabica Seed, Roasted in 1 product
- Strychnos Nux-vomica Seed in 1 product
- Sanguinaria Canadensis Root in 1 product
- Spigelia Marilandica Root in 1 product
Headache Relief NDC products (41)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69168-285 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Allegiant Health | OTC MONOGRAPH DRUG |
| 46122-690 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Amerisource Bergen | OTC MONOGRAPH DRUG |
| 70000-0146 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Cardinal Health 110, LLC. DBA Leader | OTC MONOGRAPH DRUG |
| 63868-485 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | CHAIN DRUG MARKETING ASSOCIATION INC | OTC MONOGRAPH DRUG |
| 83324-331 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Chain Drug Marketing Association, Inc. | OTC MONOGRAPH DRUG |
| 59779-334 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | CVS Pharmacy | OTC MONOGRAPH DRUG |
| 69842-586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | CVS Pharmacy | OTC MONOGRAPH DRUG |
| 55910-686 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 55910-345 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | DOLGENCORP, LLC | OTC MONOGRAPH DRUG |
| 49035-786 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | OTC MONOGRAPH DRUG |
| 55319-511 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Family Dollar (FAMILY WELLNESS) | OTC MONOGRAPH DRUG |
| 85828-285 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Grocery Outlet | OTC MONOGRAPH DRUG |
| 37808-586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | H E B | OTC MONOGRAPH DRUG |
| 41226-370 | Caffeine 65 mg/1; Aspirin 250 mg/1; Acetaminophen 250 mg/1 Tablet, Coated | Kroger Company | OTC MONOGRAPH DRUG |
| 50844-258 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | L.N.K. International, Inc. | OTC MONOGRAPH DRUG |
| 41250-334 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Meijer Distribution Inc | OTC MONOGRAPH DRUG |
| 59726-586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Coated | P & L Development, LLC | OTC MONOGRAPH DRUG |
| 59726-011 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | P & L Development, LLC | OTC MONOGRAPH DRUG |
| 56062-934 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Publix Super Markets Inc | OTC MONOGRAPH DRUG |
| 11822-3343 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Rite Aid Corporation | OTC MONOGRAPH DRUG |
| 21130-586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Safeway, Inc. | OTC MONOGRAPH DRUG |
| 57243-159 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Salado Sales, Inc. | OTC MONOGRAPH DRUG |
| 57243-334 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Salado Sales, Inc. | OTC MONOGRAPH DRUG |
| 70692-142 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Coated | Strive Pharmaceuticals Inc. | OTC MONOGRAPH DRUG |
| 11673-686 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | TARGET Corporation | OTC MONOGRAPH DRUG |
| 11673-070 | Aspirin 250 mg/1; Acetaminophen 250 mg/1; Caffeine 65 mg/1 Tablet, Coated | TARGET CORPORATION | OTC MONOGRAPH DRUG |
| 30142-586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | The Kroger Co. | OTC MONOGRAPH DRUG |
| 30142-625 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | The Kroger Co. | OTC MONOGRAPH DRUG |
| 30142-865 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | The Kroger Co. | OTC MONOGRAPH DRUG |
| 41163-334 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | United Natural Foods, Inc. dba UNFI | OTC MONOGRAPH DRUG |
| 63941-159 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Valu Merchandisers Company | OTC MONOGRAPH DRUG |
| 49035-433 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Wal-Mart Stores Inc | OTC MONOGRAPH DRUG |
| 0363-0770 | Aspirin 250 mg/1; Acetaminophen 250 mg/1; Caffeine 65 mg/1 Tablet, Coated | WALGREENS | OTC MONOGRAPH DRUG |
| 0363-7012 | Aspirin 250 mg/1; Caffeine 65 mg/1; Acetaminophen 250 mg/1 Tablet | WALGREENS | OTC MONOGRAPH DRUG |
| 0363-1150 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Walgreens | OTC MONOGRAPH DRUG |
| 0363-0865 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Walgreens | OTC MONOGRAPH DRUG |
| 0363-0586 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Walgreens | OTC MONOGRAPH DRUG |
| 79903-370 | Acetaminophen 250 mg/1; Caffeine 65 mg/1; Aspirin 250 mg/1 Tablet | Walmart Inc. | OTC MONOGRAPH DRUG |
| 67091-112 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 61727-305 | Atropa Belladonna 8 [hp_C]/4g; Cyclamen Purpurascens Tuber 8 [hp_C]/4g; Coffea Arabica Seed, Roasted 4 [hp_C]/4g; Iris… Pellet | Homeocare Laboratories | UNAPPROVED HOMEOPATHIC |
| 54973-4008 | Gelsemium Sempervirens Root 6 [hp_X]/1; Ipecac 6 [hp_X]/1; Atropa Belladonna 12 [hp_X]/1; Iris Versicolor Root 6… Tablet | Hyland's Inc. | UNAPPROVED HOMEOPATHIC |
Frequently asked questions
What is Headache Relief used for?
Uses temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches toothache premenstrual and menstrual cramps
Who makes Headache Relief?
Headache Relief is listed by 33 labelers in the FDA NDC directory, including Allegiant Health, Amerisource Bergen, Cardinal Health 110, LLC. DBA Leader, CHAIN DRUG MARKETING ASSOCIATION INC.