FDA.reportPublic FDA data

Acetaminophen

Manufacturer
WALGREEN CO.
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:27:23

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

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

Dosage and administration

■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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 between 20-25°C (68-77°F).See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each Caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

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

WARNINGS SECTION

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

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Promt 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 caplets every 6 hours while symptoms last

■ do not take more than 6 caplets 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 between 20-25°C (68-77°F).See USP Controlled Room Temperature

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or 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

APAP 100ct cartonAPAP 100ct carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN8
198440acetaminophen 500 MG Oral TabletSCD8
198440APAP 500 MG Oral TabletSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9595-10Acetaminophen100 in 1 BOTTLETABLET1008

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-95950363-9595-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
POVIDONEFZ989GH94EIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

Source Document#

Source XML

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
AcetaminophenACETAMINOPHENWALGREEN CO.b8a855ae-c0a3-0b05-e053-2a95a90ac8a82025-12-19WarningsExact identifier
ndc (package): 0363-9595-10
ndc (product): 0363-9595
ndc11 (package): 00363959510
spl id: 46531b40-2e75-7767-e063-6394a90ab1fe
spl set id: b8a855ae-c0a3-0b05-e053-2a95a90ac8a8

Reported adverse events (FAERS/openFDA)#

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