FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
Walgreens Co.
Effective date
2022-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:37

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure11 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 & children 12 years of age and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by doctor do not take more than 10 days, unless directed by a doctor children under 12 years of age ask a doctor

Storage and handling

store at room temperature between 20-25° C (68-77° F) avoid excessive heat, cold and humidity close cap tightly after use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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 have ever had an allergic reaction to this product or any of its ingredients.

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

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.

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.

OVERDOSE WARNING

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as 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 & children 12 years of age and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by doctor
  • do not take more than 10 days, unless directed by a doctor
children under 12 years of age
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature between 20-25° C (68-77° F)
  • avoid excessive heat, cold and humidity
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1 (888) 577-8033

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BONUS SIZE | 24 + 6 FREE
NDC 0363-0143-03

Walgreens

Compare to Tylenol® Extra Strength
Caplets active ingredient††

Pain Reliever
ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER

EXTRA STRENGTH
CAPLETS

30 CAPLETS

ACTUAL SIZE

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0143-032024-01-30C16284748780-11030e365-700c-111a-e063-dadaa90a10e2ACETAMINOPHEN
0363-0143-062024-01-30C16284748780-11030e365-700c-111a-e063-dadaa90a10e2ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0143-03ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED12
0363-0143-03ACETAMINOPHEN30 in 1 BOTTLETABLET, FILM COATED302
0363-0143-06ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED12
0363-0143-06ACETAMINOPHEN60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0143ACETAMINOPHEN TABLET, FILM COATED [WALGREENS CO.]2Legacy NDC, 4 package rows20220519_e87e5993-4ea7-4c27-89c4-1b81a6b673c0.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-01430363-0143-03, 0363-0143-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
hypromellose, unspecified3NXW29V3WOIACT
magnesium stearate70097M6I30IACT
microcrystalline celluloseOP1R32D61UIACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
povidone, unspecifiedFZ989GH94EIACT
stearic acid4ELV7Z65APIACT
talc7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT

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
35c4aea6-6726-4d18-b6d1-5df6bc5e76bbe87e5993-4ea7-4c27-89c4-1b81a6b673c02022-05-06WarningsExact identifier
spl id: 35c4aea6-6726-4d18-b6d1-5df6bc5e76bb
spl set id: e87e5993-4ea7-4c27-89c4-1b81a6b673c0

Reported adverse events (FAERS/openFDA)#

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