Indications and uses
temporarily relieves minor aches and pains
temporarily relieves minor aches and pains
do not use more than directed (see overdose warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12: ask a doctor
ACETAMINOPHEN 250 MG
ASPIRIN 250 MG (nsaid*)
CAFFEINE 65 MG
*nonsteroidal anti-inflammatory drug
PAIN RELIEVER - PAIN RELIEVER AID
REYE'S SYNDROME:
Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.
ALLERY ALERT
Aspirin may cause a severe allergic reaction which may include:
hives
facial swelling
asthma (sheezing)
shock
LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount;
with other drugs containing acetaminophen;
3 or more alcoholic drinks every day while usng 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 (anticogulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)
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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking
Stop use and ask a doctor if
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.
Overdose Warning: Taking more than the recommended dose
(overdose) may cause liver damage. 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, cellulose,
hypromellose, mineral oil, povidone, silica, sodium starch
glycolate, starch, stearic acid, titanium dioxide
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-231-00 | EA - Each | 68016-231 | b90ff101-f59a-4c91-a780-c5d5574fdd1c | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68016-231 | 68016-231-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| b6845a90-7a62-1512-e053-2995a90a4daf | 61b974fb-9ab2-44b8-e053-2991aa0afe83 | 2020-12-15 | Warnings | b6845a90-7a62-1512-e053-2995a90a4daf 61b974fb-9ab2-44b8-e053-2991aa0afe83 |
Adverse event summaries are temporarily unavailable. Other product information remains available.