Extra Strength Acetaminophen

Manufacturer
Walgreens Company | Hi-Tech Nutraceuticals, LLC | Hi-Techn Nutraceutical, LLC
Effective date
2022-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:49

Label at a glance#

ProductExtra Strength Acetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Drug FactsActive Ingredient Drug Facts

OTC - ASK DOCTOR SECTION

Ask a Doctor Drug FactsAsk a Doctor Drug Facts

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a Doc or Pharm Drug FactsAsk a Doc or Pharm Drug Facts

OTC - DO NOT USE SECTION

Do not UseDo not Use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reachKeep out of reach

OTC - PREGNANCY OR BREAST FEEDING SECTION

PregnantPregnant

OTC - PURPOSE SECTION

PurposePurpose

OTC - QUESTIONS SECTION

Questions or Comments? Call

OTC - STOP USE SECTION

Stop UseStop Use

OTC - WHEN USING SECTION

DirectionsDirections

WARNINGS SECTION

WarningsWarnings

STORAGE AND HANDLING SECTION

Other InformationOther Information

INACTIVE INGREDIENT SECTION

InactivesInactives

INDICATIONS & USAGE SECTION

UsesUses

DOSAGE & ADMINISTRATION 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-6973-022024-01-30C16284748780-11030e365-638b-111a-e063-dadaa90a10e2Walgreens 125-Count Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6973-02Extra Strength Acetaminophen125 in 1 BOTTLE, PLASTICTABLET1254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6973EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [WALGREENS COMPANY]4Legacy NDC, 1 package rows20230101_ac079b3f-f4e6-671b-e053-2995a90a65c5.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-69730363-6973-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
f11c9344-b728-4cb2-e053-2a95a90aa8a0ac079b3f-f4e6-671b-e053-2995a90a65c52022-12-31WarningsExact identifier
spl id: f11c9344-b728-4cb2-e053-2a95a90aa8a0
spl set id: ac079b3f-f4e6-671b-e053-2995a90a65c5

Reported adverse events (FAERS/openFDA)#

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