Indications and 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
Acetaminophen
- Manufacturer
- WALGREENS
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:28
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections
Dosage and administration
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 tablets every 6 hours while symptoms last ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor
Storage and handling
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ do not use if imprinted safety seal under cap is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each coated tablet)
Acetaminophen USP, 500 mg
Purpose
Pain reliever/fever reducer
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
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
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 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
Keep out of the reach of children.
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.
Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 tablets every 6 hours while symptoms last
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
Other information
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ do not use if imprinted safety seal under cap is broken or missing
Inactive ingredients
FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, povidone k-30, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide.
Questions or comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9538-25 | Acetaminophen | 225 in 1 BOTTLE | TABLET | 225 | 5 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- SUCRALOSE
- POLYVINYL ALCOHOL, UNSPECIFIED
- TALC
- TITANIUM DIOXIDE
- STARCH, CORN
- FD&C YELLOW NO. 6
- LECITHIN, SOYBEAN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE K30
- FD&C RED NO. 40
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-9538 | 0363-9538-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 | WALGREENS | e467b78e-9f23-5563-e053-2a95a90a586e | 2025-12-19 | Warnings | 0363-9538-25 0363-9538 00363953825 4653d906-5cc3-bfd4-e063-6294a90a9b9f e467b78e-9f23-5563-e053-2a95a90a586e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.