ACETAMINOPHEN
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Effective date
- 2025-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:09
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
For the temporary relief of minor aches and pains associated with
headache
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps
For the reduction of fever.
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 tablets in 24 hours, which is the maximum daily amount
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
OTC - STOP USE SECTION
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.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
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 using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swelling is present
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away. 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
Directions
do not use more than directed
Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years:Do not give to children under 12 years of age
OTHER SAFETY INFORMATION
Other information
store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain
QUESTIONS
Questions or comments?1-800-777-4908
OTC - ASK DOCTOR SECTION
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
OTC - STOP USE SECTION
Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swelling is present
If pregnant or breast-feeding,ask a health professional before use.
HOW SUPPLIED SECTION
51662-1666-2 2Pack
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1666-2 | ACETAMINOPHEN | 2 in 1 PACKET | TABLET | 2 | 1 | |
| 51662-1666-2 | ACETAMINOPHEN | 0.5 g in 1 POUCH | TABLET | 0.5 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51662-1666 | ACETAMINOPHEN TABLET [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 1 | Current NDC, 2 package rows | 20250519_35478de8-50d0-5d0a-e063-6294a90a88ba.zip |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- TITANIUM DIOXIDE
- STEARIC ACID
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSES
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51662-1666 | 51662-1666-2 |
| 68599-4681 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE | FZ989GH94E | 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 | HF Acquisition Co LLC, DBA HealthFirst | 35478de8-50d0-5d0a-e063-6294a90a88ba | 2025-05-16 | Warnings | 51662-1666-2 51662-1666 51662166602 35478de8-50d1-5d0a-e063-6294a90a88ba 35478de8-50d0-5d0a-e063-6294a90a88ba |
| Acetaminophen | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | 68599-4681 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
