Indications and uses
To reduce fever and for the temporary relief of minor aches and pains due to: headache muscular aches backache minor pain from arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever.
To reduce fever and for the temporary relief of minor aches and pains due to: headache muscular aches backache minor pain from arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever.
Do not take more than directed Adults and Children 12 years and over: take 2 tablets every 4 to 6 hours while symptoms last. do not take more than 10 tablets in 24 hours. do not take for more than 10 days unless directed by a doctor Children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last. do not take more than 5 tablets in 24 hours. do not use for more than 5 days unless directed b...
Active Ingredient (in each tablet) Purpose
Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer
To reduce fever and for the temporary relief of minor aches and
pains due to:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days in adults and children.
• pain gets worse or lasts more than 5 days in children under 12 years.
• fever gets worse or lasts more than 3 days.
• new symptoms occur.
• redness or swelling is present.
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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not take more than directed
Adults and Children 12 years and over:
Children 6 years to under 12 years:
Children under 6 years:
ask a doctor
Other Information
Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.
Questions and Comments? Call 1-844-474-7464
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/2258
Issued: 07/2025 (S-069-00)
†This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol® Regular strength.
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 5723734610 | acetaminophen-tabs-8608-8609-2.jpg, acetaminophen-tabs-8608-8609-1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8608-05 | Acetaminophen | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | 1 | |
| 0615-8608-30 | Acetaminophen | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | 1 | |
| 0615-8608-30 | Acetaminophen | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 1 | |
| 0615-8608-39 | Acetaminophen | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-346-01 | EA - Each | 57237-346 | 2ccb0212-ce31-48f1-bb7c-e48bd05936bd | 1 | 2025-08-11 |
| 57237-346-10 | EA - Each | 57237-346 | 39d36403-64f2-4dbf-ad05-c27fd026367a | 1 | 2025-11-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0615-8608 | 0615-8608-39, 0615-8608-05, 0615-8608-30 |
| 57237-346 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | 0615-8608-39 0615-8608-05 0615-8608-30 0615-8608 00615860830 00615860839 00615860805 7424cb7d-be03-4957-8e5c-976a13aa811a 1f4ac0e6-e986-4c22-8248-0691d64e1a30 |
| Acetaminophen | ACETAMINOPHEN | Rising Pharma Holdings, Inc. | bd5e6804-4df4-4a65-92e4-faa3a0f7c005 | 2025-07-22 | Warnings | 57237-346 |
Adverse event summaries are temporarily unavailable. Other product information remains available.