Indications and uses
Temporarily relieves minor aches and pains due to: headache a cold arthritis backache muscular aches toothache premenstrual & menstrual cramps
Temporarily relieves minor aches and pains due to: headache a cold arthritis backache muscular aches toothache premenstrual & menstrual cramps
do not use more than directed Fully dissolve 2 tablets in a glass of water and drink Adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours. Children under 12 years: do not use.
each tablet contains: sodium 416 mg store at room temperature (59°-86°F) Read all product information before using.
Drug Facts
Temporarily relieves minor aches and pains due to:
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.
If pregnant or breast-feeding, ask a health care 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.
anhydrous citric acid, docusate sodium, FD&C yellow #6 aluminum lake, flavors, leucine, magnesium citrate, mannitol, povidone, sodium benzoate, sodium bicarbonate, sucralose
Call 1-888-707-3713
DISTRIBUTED BY MARGA LABS, LLC
CINCINNATI, OHIO 45241
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2474495 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Effervescent Oral Tablet | PSN | 1 |
| 2474495 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Effervescent Oral Tablet | SCD | 1 |
| 2474495 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Effervescent Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78612-110-20 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2151-0266-e053-dadaa90a7c1a | Splizz Pain Reliever - Orange-flavored Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78612-110-20 | Splizz Pain Reliever - Orange-flavored | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 78612-110-20 | Splizz Pain Reliever - Orange-flavored | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78612-110 | 78612-110-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Aspirin | R16CO5Y76E | ACTIB |
| Caffeine | 3G6A5W338E | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| Sodium bicarbonate | 8MDF5V39QO | IACT |
| Mannitol | 3OWL53L36A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| Acesulfame potassium | 23OV73Q5G9 | IACT |
| Aspartame | Z0H242BBR1 | IACT |
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 |
|---|---|---|---|---|---|---|
| f966aea6-d108-4f68-9f20-d1c827f86171 | 94e126c4-8987-400d-bd63-4e5993db4bf9 | 2021-01-15 | Warnings | f966aea6-d108-4f68-9f20-d1c827f86171 94e126c4-8987-400d-bd63-4e5993db4bf9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.