ACETAMINOPHEN
- Manufacturer
- AARNA USA INC.
- Effective date
- 2025-04-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:56
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose
Pain Reliever/Fever Reducer
INDICATIONS & USAGE SECTION
Uses
To reduce fever and for the temporary relief of minor aches and pains due to:
•headache
•muscular aches
•backache
•minor pain of arthritis
•the common cold
•toothache
•premenstrual and menstrual cramps.
•Temporarily reduces fever.
WARNINGS SECTION
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if the user has ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if the user has
- has liver disease
- is a child with pain of arthritis
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if:
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
OVERDOSAGE SECTION
- do not take more than directed (see
overdose warning)
|
|
children 6-11 years |
|
child under 6 years | ask a doctor |
OTHER SAFETY INFORMATION
Other information
- store at 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
- Gelatinized starch, magnesium stearate, povidone
OTC - QUESTIONS SECTION
Questions or comments?
call toll-free 1-877-225-6999.
Manufactured for:
AARNA USA INC.
Leland, NC-28451
* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82568-0001-1 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 82568-0001-2 | ACETAMINOPHEN | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 82568-0001-3 | ACETAMINOPHEN | 100 in 1 PACKAGE | TABLET | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82568-0001 | ACETAMINOPHEN TABLET [AARNA USA INC.] | 1 | Current NDC, 3 package rows | 20250515_33f0e822-28af-9bb2-e063-6294a90a5175.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82568-0001-1 | EA - Each | 82568-0001 | 9d4d0671-4c10-4aa6-a76d-006ffe1df78d | 1 | 2025-07-08 |
| 82568-0001-2 | EA - Each | 82568-0001 | 1cf585a7-9ae3-42bd-867a-cabf73be92ae | 1 | 2025-07-08 |
| 82568-0001-3 | EA - Each | 82568-0001 | 906110ea-e74b-41bb-a2d0-c58aaa1c2ff1 | 1 | 2025-07-08 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- STARCH, CORN
- POVIDONE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82568-0001 | 82568-0001-1, 82568-0001-2, 82568-0001-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Source Document#
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 | AARNA USA INC. | 33f0e822-28af-9bb2-e063-6294a90a5175 | 2025-04-29 | Warnings | 82568-0001-3 82568-0001-1 82568-0001-2 82568-0001 82568000103 82568000102 82568000101 33f0e822-28b0-9bb2-e063-6294a90a5175 33f0e822-28af-9bb2-e063-6294a90a5175 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
