OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (In Each Tablet)
Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg
Active Ingredients (In Each Tablet)
Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg
Pain reliever, Stimulant
Uses: For the temporary relief of pain from:
• headaches • colds • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • backaches
Warnings:
Reye's Syndrome: 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.
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, with other drugs containing acetaminophen (prescription or non-prescription), or have 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), 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 an NSAID, or take more or for a longer time than directed.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
Directions:
Adults and children: (12 years and older) Take 1 to 2 tablets with a full glass of water every 4 hours as needed. Do not exceed 6
tablets in 24 hours, or as directed by doctor.
Children: (under 12 years) Do not give to children under 12 years of age
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
| 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 |
|---|---|---|---|---|---|
| 51532-0242-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-15f2-0266-e053-dadaa90a7c1a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51532-0242-2 | Pain Free | 2 in 1 PACKET | TABLET | 2 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51532-0242 | PAIN FREE (ACETAMINOPHEN, ASPIRIN, CAFFEINE, SALICYLAMIDE) TABLET [AFASSCO INC.] | 3 | Legacy NDC, 1 package rows | 20161128_b2a70284-f183-4d65-928e-057709f32a1f.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51532-0242 | 51532-0242-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| SALICYLAMIDE | EM8BM710ZC | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | 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 |
|---|---|---|---|---|---|---|
| 386b5f2b-fd2b-4919-8b95-7836bd26097b | b2a70284-f183-4d65-928e-057709f32a1f | 2016-11-28 | Warnings | 386b5f2b-fd2b-4919-8b95-7836bd26097b b2a70284-f183-4d65-928e-057709f32a1f |
Adverse event summaries are temporarily unavailable. Other product information remains available.