FDA.reportPublic FDA data

Acetaminophen 500mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:43

Label at a glance#

ProductAcetaminophen 500mg
Active ingredientACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycolate

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • do not take more than directed
adults and 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 a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years of age ask a doctor

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 SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000mg 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

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). 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

  • liver disease

Ask a doctor or a pharmacist before use if

you are taking the blood thinning drug warfarin

Stop use 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 comdition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

Pain reliever / Fever reducer

OTHER SAFETY INFORMATION

  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB11706LB11706CT11706CT11706CT11741CT11741

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-117-062022-01-28C16284748780-1d6a99b39-4a87-a426-e053-dadaa90af4c2Acetaminophen 500mg
70692-117-412022-01-28C16284748780-1d6a99b39-4a87-a426-e053-dadaa90af4c2Acetaminophen 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-117-06Acetaminophen 500mg60 in 1 BOTTLETABLET603
70692-117-41Acetaminophen 500mg4 in 1 PACKAGETABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-117ACETAMINOPHEN 500MG TABLET [STRIVE PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20201117_92210dcd-a87f-2b74-e053-2a95a90ac034.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-11770692-117-41, 70692-117-06

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
SILICON DIOXIDEETJ7Z6XBU4IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

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
b43d776e-b5f3-16b9-e053-2995a90a66b992210dcd-a87f-2b74-e053-2a95a90ac0342020-11-16WarningsExact identifier
spl id: b43d776e-b5f3-16b9-e053-2995a90a66b9
spl set id: 92210dcd-a87f-2b74-e053-2a95a90ac034

Reported adverse events (FAERS/openFDA)#

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