Walgreens Acetaminophen Film Coated Red Tablets, 500 mg

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-13 04:05:13

Label at a glance#

ProductExtra Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each tablet)
Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses
temporarily relieves minor aches and pains due to:

  • headache
  • the common cold
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps

temporarily reduces fever

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.

OTC - DO NOT USE SECTION

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 poduct

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

OTC - STOP USE SECTION

Stop using 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.

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: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

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 use for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information

  • store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized
starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient

OTC - QUESTIONS SECTION

Questions and comments?Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

342R-Walgreens-Pain-Reliever-bottle-label-50s342R-Walgreens-Pain-Reliever-bottle-label-50s

342R_WALG_50CT_IFC342R_WALG_50CT_IFC

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-06840363-0684-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-30full-release2026-06-01 00:54:43

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
2cf9dc98-8683-e0ad-e063-6394a90a971dc25bcfdc-3119-0e8e-e053-2995a90a9e492025-01-30WarningsExact identifier
spl set id: c25bcfdc-3119-0e8e-e053-2995a90a9e49

Reported adverse events (FAERS/openFDA)#

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