Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Drug Facts
- Manufacturer
- P & L Development, LLC
- Effective date
- 2026-06-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-14 00:01:43
Label at a glance#
ProductHeadache Relief Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections
Dosage and administration
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
Storage and handling
store between 20º-25ºC (68º-77ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each geltab)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
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
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.
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
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 or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO Excedrin® Extra Strength active ingredients†
Extra Strength
Headache Relief
ACETAMINOPHEN 250 mg
ASPIRIN (NSAID) 250 mg
CAFFEINE 65 mg
Pain Reliever/Pain Reliever Aid
GELTABS
†This product is not manufactured or distributed by Haleon Group of Companies, distributor of Excedrin® Extra Strength.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY
PL DEVELOPMENTS
200 Hicks Street
Westbury, NY 11590
Package Label green
Products#
Every source-derived product name is available through these pages.
- Headache Relief Extra Strength
- Acetaminophen, Aspirin, Caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- STARCH, CORN
- HYPROMELLOSES
- POVIDONE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- EDETATE DISODIUM
- GELATIN
- GLYCERIN
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- MALTITOL
- WATER
- ALUMINUM OXIDE
- HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59726-586 | 59726-586-80 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-06-12 | monthly-update | 2026-07-17 21:34:59 |
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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | 55e996cd-ef22-4e09-a05c-8aa994e4540b | 2026-06-12 | Warnings | 59726-586-80 59726-586 59726058680 2cf01c31-a85c-4e59-9714-f3ba6be0443d 55e996cd-ef22-4e09-a05c-8aa994e4540b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.