Indications and uses
temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period Children under 12 years: Ask a doctor
Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer
Aspirin 162 mg .....................................................................................................pain reliever/fever reducer
Caffeine 32.4 mg...............................................................................................................................adjuvant
Salicylamide 152 mg............................................................................................pain reliever/fever reducer
temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.
This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
This product contains a non-steroidal anti-inflammatory drug (NSAIDs), which may cause stomach bleeding. The chance is higher if you ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ have 3 or more alcoholic drinks every day while using this product ■ take with other drugs containing a NSAID ■ you take more or for a longer time than directed.
■ if you are allergic to aspirin ■ with any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor ■ with any other product containing acetaminophen
■ asthma ■ stomach problems (such as heartburn, upset stomach or stomach pain) ■ gastric ulcers ■ bleeding problems
you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis
■ ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present
ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
In a case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period
Children under 12 years: Ask a doctor
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity
FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch and stearic acid
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 359221 | acetaminophen 110 MG / aspirin 162 MG / salicylamide 152 MG / caffeine 32.4 MG Oral Tablet | PSN | 3 |
| 359221 | acetaminophen 110 MG / aspirin 162 MG / caffeine 32.4 MG / salicylamide 152 MG Oral Tablet | SCD | 3 |
| 359221 | APAP 110 MG / ASA 162 MG / Caffeine 32.4 MG / salicylamide 152 MG Oral Tablet | SY | 3 |
| 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 |
|---|---|---|---|---|---|
| 71105-242-68 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0522-0266-e053-dadaa90a7c1a | Pain Reliever |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71105-242-68 | Extra Strength Pain Reliever | 100 in 1 CARTON | TABLET | 100 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71105-242 | 71105-242-68 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SALICYLAMIDE | EM8BM710ZC | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| c62a10de-a02c-308c-e053-2995a90a8f59 | 47df5786-b918-3a3e-e054-00144ff88e88 | 2021-07-02 | Warnings | c62a10de-a02c-308c-e053-2995a90a8f59 47df5786-b918-3a3e-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.