Active ingredient

Manufacturer
Walgreens | Granules Consumer Health, LLC | Granules Life Sciences
Effective date
2026-08-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-28 00:02:11

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

■ temporarily relieves 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

Dosage and administration

■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not use for 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). ■ avoid high humidity ■ see end panel for expiration date and lot number (carton) ■ see bottom of label for expiration date and lot number (label)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg Pain reliever/fever reducer

Purpose

OTC - PURPOSE SECTION

Pain reliever/ Fever reducer

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves 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

WARNINGS SECTION

Warnings
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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Stop use and ask a doctor if

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.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Overdose warning

OVERDOSAGE SECTION

In case of accidental 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

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store at 20°-25°C (68°-77°F).
■ avoid high humidity
■ see end panel for expiration date and lot number (carton)
■ see bottom of label for expiration date and lot number (label)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Questions and comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Acetaminophen 500mgPain Relief Acetaminophen 500mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-98100363-9810-50, 0363-9810-10, 0363-9810-25, 0363-9810-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-08-20daily-update2026-08-25 01:03:26

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
ndc (package): 0363-9810-50
ndc (package): 0363-9810-25
ndc (package): 0363-9810-10
ndc (package): 0363-9810-75
ndc (product): 0363-9810
ndc11 (package): 00363981025
ndc11 (package): 00363981075
ndc11 (package): 00363981010
ndc11 (package): 00363981050
spl id: 59d03f57-1366-f80d-e063-6294a90a4519
spl set id: 543f93d1-df14-0bd2-e063-6294a90a4413

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.