Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain from arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen
- Manufacturer
- Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
- Effective date
- 2025-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:42:11
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts
Active Ingredient (in each caplet) Purpose
Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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
- 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: 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.
DOSAGE & ADMINISTRATION SECTION
Other information
- SODIUM FREE
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- see end panel for lot number and expiration date.
Inactive ingredients
Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-844-474-7464
†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/2258
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Extra Strength
Acetaminophen
500 mg
NDC 57237-347-05
500 Film Coated Caplets
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-347-01 | Acetaminophen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 | |
| 57237-347-05 | Acetaminophen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-347-01 | EA - Each | 57237-347 | 4f6789ab-9c2c-4ac7-a464-2a6e97d0c88b | 1 | 2025-08-11 |
| 57237-347-05 | EA - Each | 57237-347 | 87c5b2bc-2c08-4480-8a77-b1524ea59b13 | 1 | 2025-11-13 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STARCH, CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57237-347 | 57237-347-01, 57237-347-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-07-01 | full-release | 2026-06-01 01:06:52 |
openFDA label cross-check#
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 | Rising Pharma Holdings, Inc. | f8237772-7656-49fb-b1de-f8fcb5fa55ee | 2025-10-28 | Warnings | 57237-347-05 57237-347-01 57237-347 57237034701 57237034705 ffbb6e36-399b-40eb-96b4-b0406c712c0d f8237772-7656-49fb-b1de-f8fcb5fa55ee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.