Indications and uses
temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches sinusitis toothache premenstrual and menstrual cramps
Headache Relief
- Manufacturer
- P & L Development, LLC
- Effective date
- 2018-12-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:39:50
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 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor
Storage and handling
store at controlled room temperature 20º-25ºC (68º-77ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
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
- arthritis
- a cold
- muscular aches
- sinusitis
- 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 8 caplets in 24 hoursm 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 thining (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for 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 whilr 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 asthma
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- 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
- taking any other drug or are under a doctor’s care for any serious condition
Stop use and ask doctor if
- 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
- an allergic reaction occurs. Seek medical help right away.
- any new symptoms appear
- 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
These could be a signs of a serious condition.
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center 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 caplets every 6 hours; do not take more than 8 caplets in 24 hours
- children under 12 years: do not use unless directed by a doctor
Other information
- store at controlled room temperature 20º-25ºC (68º-77ºF)
Inactive ingredients
carnauba wax**, colloidal silicon dioxide, corn starch, hypromellose, maltodextrin**, microcrystalline cellulose, mineral oil**, polydextrose**, povidone, sodium starch glycolate**, stearic acid, talc**, titanium dioxide, triglycerides**
**contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Excedrin® Extra Strength†
Extra Strength
Headache Relief
Acetaminophen
Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid
Caplets
†This product is not manufactured or distributed by Novartis, 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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 1 | |
| C10-18 TRIGLYCERIDES | INACTIVE INGREDIENT | 43AGM4PHPI | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Headache Relief Extra Strength
- Acetaminophen, Aspirin, Caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- CARNAUBA WAX
- SILICON DIOXIDE
- STARCH, CORN
- HYPROMELLOSES
- MALTODEXTRIN
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- POLYDEXTROSE
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- C10-18 TRIGLYCERIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59726-247 | 59726-247-24, 59726-247-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| C10-18 TRIGLYCERIDES | 43AGM4PHPI | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, COATED / ORAL | 5.6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg |
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 |
|---|---|---|---|---|---|---|
| 1ab0a2fa-2d71-4d77-855f-8762dd3933de | 9dfabfa3-a3d7-4076-a65c-9e3310826738 | 2018-12-21 | Warnings | 1ab0a2fa-2d71-4d77-855f-8762dd3933de 9dfabfa3-a3d7-4076-a65c-9e3310826738 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.