EXTRA STRENGTH HEADACHE RELIEF
- Manufacturer
- WAL-MART STORES INC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:07:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
Pain reliever
Pain reliever aid
INDICATIONS & USAGE SECTION
Uses
temporarily relieves minor aches and pains due to:
• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps
WARNINGS SECTION
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:
• 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:
• 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 heartbeat.
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
• 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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- 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, consult a doctor before taking any more of this product
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor
OTHER SAFETY INFORMATION
Other information
• store at 20°- 25°C (68°- 77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79903-044-20 | EXTRA STRENGTH HEADACHE RELIEF | 200 in 1 BOTTLE | TABLET, COATED | 200 | 2 | |
| 79903-044-42 | EXTRA STRENGTH HEADACHE RELIEF | 1 in 1 CARTON | TABLET, COATED | 1 | 2 | |
| 79903-044-42 | EXTRA STRENGTH HEADACHE RELIEF | 24 in 1 BOTTLE | TABLET, COATED | 24 | 2 |
Products#
Every source-derived product name is available through these pages.
- EXTRA STRENGTH HEADACHE RELIEF
- ACETAMINOPHEN ASPIRIN CAFFEINE
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE
- STEARIC ACID
- CARNAUBA WAX
- SODIUM STARCH GLYCOLATE TYPE A CORN
- TITANIUM DIOXIDE
- HYPROMELLOSES
- MINERAL OIL
- STARCH, CORN
- ASPIRIN
- ACETAMINOPHEN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79903-044 | 79903-044-20, 79903-044-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH HEADACHE RELIEF | ACETAMINOPHEN ASPIRIN CAFFEINE | WAL-MART STORES INC | d97073cd-b5d7-8c09-e053-2a95a90a8938 | 2025-07-16 | Warnings | 79903-044-42 79903-044-20 79903-044 79903004420 79903004442 3a07455b-2d93-ed7f-e063-6394a90a45c2 d97073cd-b5d7-8c09-e053-2a95a90a8938 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


