Indications and uses
temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches toothache premenstrual and menstrual cramps
temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches 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 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
store at controlled room temperature 20º-25ºC (68º-77ºF)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
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:
If a skin reaction occurs, stop use and seek medical help right away
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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.
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.
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
Call 1-800-910-6874
Compare to active ingredients in Excedrin® Extra Strength†
Headache Relief
Pain Reliever
Pain Reliever Aid
Acetaminophen, 250 mg, Aspirin (NSAID), 250 mg
Caffeine, 65 mg
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.
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| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11673-247 | 11673-247-10, 11673-247-27 |
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 |
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 |
|---|---|---|---|---|---|---|
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg |
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 |
|---|---|---|---|---|---|---|
| 76d94744-c471-4c6c-8894-5733d2df37ec | 4979761a-86ca-4bb1-8983-70eb490f352f | 2019-06-27 | Warnings | 76d94744-c471-4c6c-8894-5733d2df37ec 4979761a-86ca-4bb1-8983-70eb490f352f |
Adverse event summaries are temporarily unavailable. Other product information remains available.