Indications and uses
temporary relieves minor aches and pains due to the common cold headache backache toothache muscular aches premenstrual and menstrual cramps and temporarily reduces fever
temporary relieves minor aches and pains due to the common cold headache backache toothache muscular aches premenstrual and menstrual cramps and temporarily reduces fever
do not use more than directed (see overdose warning) Adults and children 12 years of age and older: Take 2 caplets every 6 hours while symptoms last. Do not take more than 6 caplets in 24 hours, unless directed by a doctor Do not use more than 10 days unless directed by a doctor. Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and...
(in each tablet)
Acetaminophen 500mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
ask a health professional before use
Overdose warning: Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide
1-844-384-3723 (Mon-Fri 9AM-5PM EST) or
www.safrelpharma.com
* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Tylenol*.
NDC 71309-001-05 500 Caplets
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-001-05 | 2025-04-23 | C162847 | 48780-1 | 0191ceaa-6357-198a-e063-dbdaa90aec3e | Acetaminophen Extra Strength 500 mg |
| 71309-001-40 | 2025-04-23 | C162847 | 48780-1 | 0191ceaa-6357-198a-e063-dbdaa90aec3e | Acetaminophen Extra Strength 500 mg |
| 71309-001-05 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6357-198a-e063-dbdaa90aec3e | Acetaminophen Extra Strength 500 mg |
| 71309-001-40 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6357-198a-e063-dbdaa90aec3e | Acetaminophen Extra Strength 500 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-001-05 | Extra Strength No-Pain | 500 in 1 BOTTLE | TABLET | 500 | 6 | |
| 71309-001-40 | Extra Strength No-Pain | 40 in 1 BOTTLE | TABLET | 40 | 6 | |
| 71309-001-40 | Extra Strength No-Pain | 1 in 1 CARTON | TABLET | 1 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71309-001 | 71309-001-05, 71309-001-40 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | 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 |
|---|---|---|---|---|---|---|
| Extra Strength No-Pain | ACETAMINOPHEN | Safrel Pharmaceuticals, LLC. | 873f01dd-0701-5fd3-e053-2a95a90a6463 | 2025-04-23 | Warnings | 71309-001-40 71309-001-05 71309-001 71309000140 71309000105 3371e8dc-ae55-9a65-e063-6394a90aeaac 873f01dd-0701-5fd3-e053-2a95a90a6463 |
Adverse event summaries are temporarily unavailable. Other product information remains available.