ACETAMINOPHEN

Manufacturer
WAL-MART STORES INC | TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2025-01-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:53:15

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each caplet)

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 8 caplets in 24 hours,which is the maximum daily amount
  • 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 product
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless dierected by a doctor

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

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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

adults and children 12 years and over

  • take 2 caplets(1,000 mg) every 6 hours while symptoms last
  • do not take more than 6 caplets(3,000 mg) in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • SODIUM FREE
  • store at 25 0C (77 0F) excursions permitted between 15 0-30 0C (59 0-86 0F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide
*may contain this ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

341r 2X500 sleeve341r 2X500 sleeve

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-755-50ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004
49035-755-88ACETAMINOPHEN1000 in 1 PACKAGETABLET, COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-755ACETAMINOPHEN TABLET, COATED [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20250121_8f221fdb-8138-c1a8-e053-2995a90a29c2.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-75549035-755-50, 49035-755-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INC8f221fdb-8138-c1a8-e053-2995a90a29c22025-01-11WarningsExact identifier
ndc (package): 49035-755-50
ndc (package): 49035-755-88
ndc (product): 49035-755
ndc11 (package): 49035075588
ndc11 (package): 49035075550
spl id: 2b6c0fa2-3f13-50df-e063-6294a90a044d
spl set id: 8f221fdb-8138-c1a8-e053-2995a90a29c2

Reported adverse events (FAERS/openFDA)#

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