FDA.reportPublic FDA data

ACETAMINOPHEN 500 MG TABLET

Manufacturer
ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:59

Label at a glance#

ProductACETAMINOPHEN 500 MG
Active ingredientACETAMINOPHEN
Label structure19 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults & children 12 years and over: take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last do not take more than 8 tablets in 24 hours children under 12 years: do not use

Storage and handling

store at 15º to 30ºC (59º to 86ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

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

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen 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

OTHER SAFETY INFORMATION

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 usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you haveliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

OTC - STOP USE SECTION

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 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:Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 & children 12 years and over:

  • take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours

children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 15º to 30ºC (59º to 86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666,8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark TYLENOL®.

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeQR Code(01)00376420488019(17)251013(10)00000000(21)262560GTIN-14: 00376420488019
GTIN-12: 376420488019
UPC-A: 376420488019
EAN-13: 0376420488019
GTIN storage (14 digits): 00376420488019		label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-488-01ACETAMINOPHEN 500 MG100 in 1 BOTTLE, PLASTICTABLET1001
76420-488-10ACETAMINOPHEN 500 MG10 in 1 BOTTLE, PLASTICTABLET101
76420-488-20ACETAMINOPHEN 500 MG20 in 1 BOTTLE, PLASTICTABLET201
76420-488-30ACETAMINOPHEN 500 MG30 in 1 BOTTLE, PLASTICTABLET301
76420-488-60ACETAMINOPHEN 500 MG60 in 1 BOTTLE, PLASTICTABLET601
76420-488-90ACETAMINOPHEN 500 MG90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-011-01EA - Each69618-0112d58ebc4-ee99-4bbc-8262-a7795e99fb3812016-01-13
69618-011-10EA - Each69618-01182753e1b-afa7-47c0-8df1-45547674470912016-01-13

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-48876420-488-01, 76420-488-10, 76420-488-20, 76420-488-30, 76420-488-60, 76420-488-90
69618-011

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
POVIDONEFZ989GH94EIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN 500 MGACETAMINOPHENASCLEMED USA INC.db8e6702-88ac-4db2-9dd8-7d0ed997c2b52025-10-14WarningsExact identifier
ndc (package): 76420-488-01
ndc (package): 76420-488-60
ndc (package): 76420-488-90
ndc (package): 76420-488-10
ndc (package): 76420-488-30
ndc (package): 76420-488-20
ndc (product): 76420-488
ndc11 (package): 76420048810
ndc11 (package): 76420048860
ndc11 (package): 76420048890
ndc11 (package): 76420048801
ndc11 (package): 76420048830
ndc11 (package): 76420048820
spl id: 411a7984-fff2-6710-e063-6394a90a1704
spl set id: db8e6702-88ac-4db2-9dd8-7d0ed997c2b5
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (product): 69618-011

Reported adverse events (FAERS/openFDA)#

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