Acetaminophen Tablets 500 mg
- Manufacturer
- McKesson | Medique Products | Allegaint Health
- Effective date
- 2024-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:31:22
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
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
OTC - QUESTIONS SECTION
Questions or comments?1-800-777-4908
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC# 68599-4681-3
McKesson
Acetaminophen Tablets 500mg
Non-Aspirin
Used to reduce fever / Temporarily relieves aches and pains
2 per Pack / 250 packs per Box
MFR# 82468
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-4681-3 | Acetaminophen | 0.5 g in 1 POUCH | TABLET | 0.5 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68599-4681 | ACETAMINOPHEN (PAIN RELIEVER) TABLET [MCKESSON] | 6 | Current NDC, 1 package rows | 20241030_9d620700-5d00-475f-e053-2995a90a9a3f.zip |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- Pain reliever
- TITANIUM DIOXIDE
- STEARIC ACID
- STARCH, CORN
- HYPROMELLOSES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68599-4681 | 68599-4681-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | 68599-4681-3 68599-4681 68599468103 258aa2cc-a345-4b45-e063-6394a90a7d56 9d620700-5d00-475f-e053-2995a90a9a3f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

