Boxed warning
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Other information store at room temperature
Active Ingredients (in each caplet)
Acetaminophen 500 mg
Purposes
Pain Reliever/fever reducer
Uses
Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if:
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
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. (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.
Directions
Other information
Inactive ingredients Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Questions or comments? If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 3 |
| 1100005 | CounterAct Pain 500 MG Oral Tablet | PSN | 3 |
| 1100005 | acetaminophen 500 MG Oral Tablet [CounterAct Pain] | SBD | 3 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 3 |
| 198440 | APAP 500 MG Oral Tablet | SY | 3 |
| 1100005 | APAP 500 MG Oral Tablet [CounterAct Pain] | SY | 3 |
| 1100005 | CounterAct Pain 500 MG Oral Tablet | SY | 3 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54473-305-50 | 2025-03-21 | C162847 | 48780-1 | 2cef2736-aae7-d83d-e063-dadaa90ab31f | CounterAct Pain Content of Labeling |
| 54473-305-50 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-aae7-d83d-e063-dadaa90ab31f | CounterAct Pain Content of Labeling |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54473-305-50 | CounterActPain | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 3 | |
| 54473-305-50 | CounterActPain | 1 in 1 BOX | TABLET, FILM COATED | 1 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54473-305 | 54473-305-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | 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 |
|---|---|---|---|---|---|---|
| CounterAct Pain | ACETAMINOPHEN | Melaleuca, Inc. | 7faf76b4-7f25-377d-e053-2a91aa0a19d4 | 2025-03-20 | Boxed warning, Warnings | 54473-305-50 54473-305 54473030550 30ce656f-cab7-9520-e063-6294a90a43ff 7faf76b4-7f25-377d-e053-2a91aa0a19d4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.