ACETAMINOPHEN 500 MG

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:51:39

Label at a glance#

ProductACETAMINOPHEN 500 MG
Active ingredientACETAMINOPHEN
Label structure19 sections

Indications and uses

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

Storage and handling

store at 20º - 25ºC (68º -77ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • muscular aches
  • 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 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 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 ingredient in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor/pharmacist before use if you are

  • taking 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
  • redness or swelling is present
  • new symptoms occur

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: In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) 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 and  children 12 years 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

  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20º - 25ºC (68º -77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 (732) 994-2808 or email support@gencare.health

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.

NDC 72090-038-01 (500ct HDPE Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0232-00 GC Pain Relief ES 500ct_page-0001PL0232-00 GC Pain Relief ES 500ct_page-0001

NDC 72090-038-02 (300ct HDPE Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0233-00 GC Pain Relief ES 300ct_page-0001PL0233-00 GC Pain Relief ES 300ct_page-0001

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-038-01ACETAMINOPHEN 500 MG500 in 1 BOTTLETABLET5001
72090-038-02ACETAMINOPHEN 500 MG300 in 1 PACKAGETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-038ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, 2 package rows20250110_e817bc4a-43ef-4126-b903-aabd1390cd0c.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
72090-03872090-038-01, 72090-038-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLCe817bc4a-43ef-4126-b903-aabd1390cd0c2025-01-08WarningsExact identifier
ndc (package): 72090-038-01
ndc (package): 72090-038-02
ndc (product): 72090-038
ndc11 (package): 72090003802
ndc11 (package): 72090003801
spl id: 2d0de82a-1213-40ed-9e49-d6d1c36c015e
spl set id: e817bc4a-43ef-4126-b903-aabd1390cd0c

Reported adverse events (FAERS/openFDA)#

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