Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
temporarily relieves minor aches and pains due to: headache a cold arthritis 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: ask a doctor
store between 20-25°C (68-77°F) in a dry place retain carton for complete product information
Drug Facts
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Aspirin (NSAID 1) 250 mg | Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
1nonsteroidal anti-inflammatory drug
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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
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 (1-800-222-1222). 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, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
NDC 68998-183-03
†Compare to the active ingredients in Excedrin® Extra Strength Caplets
Marc’s®
Extra Strength
Headache Relief
Pain Reliever/ Pain Reliever Aid
Acetaminophen, Aspirin (NSAID) & Caffeine
100 Caplets
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68998-183 | 68998-183-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ee9dec75-27d4-6fb6-e053-2995a90a260e | 76ef2ac1-cfd3-4ce6-bf93-fa2607e57e64 | 2022-11-29 | Warnings | 76ef2ac1-cfd3-4ce6-bf93-fa2607e57e64 |
Adverse event summaries are temporarily unavailable. Other product information remains available.