FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Velocity Pharma LLC
Effective date
2018-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:33

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning). Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last. do not take more than 6 caplets of this product 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

ask a doctor before use if you have liver disease

ask your doctor or 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
  • redness or swelling is present
  • new symptoms appear

  • these could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for 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 and children 12 years and over:
  • take 2 caplets every 6 hours while symptoms last.
  • do not take more than 6 caplets of this product 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 Information

SPL UNCLASSIFIED SECTION

  • Store at a controlled temperature between  62° and 77 °F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

P.G Starch, P.V.P.K.30, sodium metabisulfite, colloidal silicon dioxide, Hypromellose-15, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Sodium Starch Glycolate, Hypromellose-6, Polyethylene Glycol, Titanium Dioxide.

Questions or Comments

OTC - QUESTIONS SECTION

Questions? 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP 60APAP 60

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-120-10Acetaminophen60 in 1 BOTTLETABLET602
76168-120-10Acetaminophen1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-120ACETAMINOPHEN TABLET [VELOCITY PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20180515_bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50.zip

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
76168-12076168-120-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE 2910 (15 MPA.S)36SFW2JZ0WIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
ndc (package): 76168-120-10
ndc (product): 76168-120
ndc11 (package): 76168012010
spl id: 6c311047-4be7-44ad-e053-2a91aa0ad047
spl set id: bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50

Reported adverse events (FAERS/openFDA)#

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