Extra Strength Acetaminophen 500 mg tablets
- Manufacturer
- Walmart Inc. | TIME CAP LABORATORIES INC | MARKSANS PHARMA LIMITED
- Effective date
- 2026-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:35:45
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
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
-the common cold
-headache
-backache
-minor pain of arthritis
-toothache
-muscular aches
-premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
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.
OTC - DO NOT 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.
- 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
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
Overdose warning: 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.
DOSAGE & ADMINISTRATION SECTION
Directions
do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
OTHER SAFETY INFORMATION
Other information
- SODIUM FREE
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide
*may contain this ingredient
OTC - QUESTIONS SECTION
Questions or comments?Call 1-888-287-1915
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0194346263639 | GTIN-13: 0194346263639 EAN-13: 0194346263639 GTIN-12: 194346263639 UPC-A: 194346263639 GTIN storage (14 digits): 00194346263639 | 342R-apap-red-.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Extra Strength Pain Reliever
- Acetaminophen
- SUCRALOSE
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- CARNAUBA WAX
- TITANIUM DIOXIDE
- FD&C RED NO. 40 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- STEARIC ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79903-342 | 79903-342-73 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C RED NO. 40 ALUMINUM LAKE | 6T47AS764T | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2024-07-31 | full-release | 2026-06-01 00:17:09 |
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 |
|---|---|---|---|---|---|---|
| Extra Strength Pain Reliever | ACETAMINOPHEN | Walmart Inc. | 152bb455-da5b-ae13-e063-6394a90acab0 | 2026-01-01 | Warnings | 79903-342-73 79903-342 79903034273 3c2499d6-95bb-0368-e063-6294a90ac054 152bb455-da5b-ae13-e063-6394a90acab0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
