Acetaminophen

Manufacturer
Prostat First Aid
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:46

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections

Indications and uses

Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily relieves fever

Dosage and administration

Do not take more than directed. (see overdose warning). Adults and children 12 years and older Take 2 tablets every 6 hours while symptoms last Do not take more than 6 tablets 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 500mg (in each tablet)

Purpose

OTC - PURPOSE SECTION

Pain Releiver / Fever Reducer

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.

If you are allergic to acetaminophen or any of the inactive ingredients in this product.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to

Common cold

headache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily relieves fever

Warnings

WARNINGS SECTION

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if:

  • adutls take more than 4000mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount.
  • taken with other drugs containing acetaminophen
  • adult has 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 ad seek medical medical help right away

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Liver Disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Keep out of reach of children

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 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 older

  • Take 2 tablets every 6 hours while symptoms last
  • Do not take more than 6 tablets 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

Stop Use and ask a doctor if

OTC - STOP USE SECTION

  • 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 a sign of a serious condition

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Overdose Warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is cretical for adults as well as children even if you do not notice symptoms.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 20ºC - 25ºC (68ºF - 77ºF)
  • Do not use if printed packet is torn or punctured
  • Read and keep carton for complete warnings and information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycoate, Stearic Acid

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-900-2920

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By:

ProStat First Aid

La Verne, CA. 91750 USA

*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

Made in the USA

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HONEYWELL NON-ASPIRIN X STRENGTH ACETAMINOPHEN TABLT 500MG 022125 CDERHONEYWELL NON-ASPIRIN X STRENGTH ACETAMINOPHEN TABLT 500MG 022125 CDER

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-1986-1Acetaminophen2 in 1 PACKETTABLET21
58228-1986-1Acetaminophen10000 in 1 BAGTABLET100001

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-198658228-1986-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
ndc (package): 58228-1986-1
ndc (product): 58228-1986
ndc11 (package): 58228198601
spl id: 3bdbeabb-6b05-5468-e063-6394a90a03c9
spl set id: 3bdbea6a-3f11-9142-e063-6294a90a20ea

Reported adverse events (FAERS/openFDA)#

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