FDA.reportPublic FDA data

Acetaminophen

Manufacturer
HealthRight Products, LLC
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:06

Label at a glance#

ProductAcetaminophen
Active ingredientAcetaminophen
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to headache tooth pain backache PMS and menstrual cramps temporarily reduces fever minor arthritis the common cold muscular pain 

Storage and handling

Store in a cool and dry place Store between 22-25˚C (67-77˚F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Important: Read all product information before using. Keep this box for important information.

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to

  • headache
  • tooth pain
  • backache
  • PMS and menstrual cramps
  • temporarily reduces fever
  • minor arthritis
  • the common cold
  • muscular pain 

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets 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 reaction. Symptoms may include:

  • skin reddening 
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You are suffering from any liver disease
  • you are taking the blood thinning drug warfarin
  • 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.

OVERDOSAGE SECTION

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. 

Dosage

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age, Take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours, unless directed by a doctor. 

Children under 12, ask a doctor. 

Storage

STORAGE AND HANDLING SECTION

  • Store in a cool and dry place
  • Store between 22-25˚C (67-77˚F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Micro crystalline Cellulose, Corn Starch, Sodium Starch Glycolate Type A, Sodium Lauryl sulfate, Sodium Methyl Paraben, Magnesium Stearate, Talc, Croscarmellose Sodium and polyvinyl pyrrolidone K-30

Information

OTHER SAFETY INFORMATION

Tamper Evident: Do not use if safety seal under cap is broken or missing

Swallow whole, do not crush, chew, split or dissolve

PRINCIPAL DISPLAY PANEL - 200 CT 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Caplet, 500 mg

Pain Reliever - Fever Reducer

image descriptionimage description

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77800-100-012022-01-28C16284748780-1d6a99b39-92ab-a426-e053-dadaa90af4c2Acetaminophen 500 mg Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77800-100-01Acetaminophen200 in 1 BOTTLETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77800-100ACETAMINOPHEN (ACETAMINOPHEN CAPLET, 500 MG EXTRA STRENGTH) TABLET [HEALTHRIGHT PRODUCTS, LLC]2Legacy NDC, 1 package rows20200730_8f78bece-25fa-4a42-90f0-c899e6644d54.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77800-10077800-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT

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
8b16d62b-4365-490c-a9c3-29f77f8589168f78bece-25fa-4a42-90f0-c899e6644d542020-07-28WarningsExact identifier
spl id: 8b16d62b-4365-490c-a9c3-29f77f858916
spl set id: 8f78bece-25fa-4a42-90f0-c899e6644d54

Reported adverse events (FAERS/openFDA)#

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