FDA.reportPublic FDA data

MAXIMUM STRENGTH NON-ASPIRIN 250

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:25:33

Label at a glance#

ProductMAXIMUM STRENGTH NON-ASPIRIN 100
Active ingredientACETAMINOPHEN
Label structure11 sections

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Storage and handling

do not use if packet is opened or torn store at room temperature 59-86℉ (15-30℃) avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Tablets)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

pain reliever/fever reducer

Use

INDICATIONS & USAGE SECTION

temporarily relieves fever and minor aches and pains associated with:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

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

  • More than 8 tablets (4000mg 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

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask 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 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

SPL UNCLASSIFIED SECTION

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. Prompt 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

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Other Information

STORAGE AND HANDLING SECTION

  • do not use if packet is opened or torn
  • store at room temperature 59-86℉ (15-30℃)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 100 Tablet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product #1122

Maximum Strength
Non-Aspirin

Active ingredient:
Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308. 1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel
Principal Display Panel

PRINCIPAL DISPLAY PANEL - 250 Tablet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product #1124

Maximum Strength
Non-Aspirin

Active ingredient:
Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308. 1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet

Principal Display Panel
Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1122-12025-12-16C16284748780-11030e365-01ad-111a-e063-dadaa90a10e2MAXIMUM STRENGTH NON-ASPIRIN
73598-1124-12025-12-16C16284748780-11030e365-01ad-111a-e063-dadaa90a10e2MAXIMUM STRENGTH NON-ASPIRIN
73598-1122-12024-01-30C16284748780-11030e365-01ad-111a-e063-dadaa90a10e2MAXIMUM STRENGTH NON-ASPIRIN
73598-1124-12024-01-30C16284748780-11030e365-01ad-111a-e063-dadaa90a10e2MAXIMUM STRENGTH NON-ASPIRIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1122-1MAXIMUM STRENGTH NON-ASPIRIN 1002 in 1 DOSE PACKTABLET23
73598-1122-1MAXIMUM STRENGTH NON-ASPIRIN 10050 in 1 BOXTABLET503
73598-1124-1MAXIMUM STRENGTH NON-ASPIRIN 250125 in 1 BOXTABLET1253
73598-1124-1MAXIMUM STRENGTH NON-ASPIRIN 2502 in 1 DOSE PACKTABLET23

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73598-112273598-1122-1
73598-112473598-1124-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT

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
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
ndc (package): 73598-1122-1
ndc (package): 73598-1124-1
ndc (product): 73598-1122
ndc (product): 73598-1124
ndc11 (package): 73598112401
ndc11 (package): 73598112201
spl id: 993e1111-cac5-47d8-8c36-d4c74b95589c
spl set id: 1d3e9948-883e-4668-9bb8-d699a283b51a

Reported adverse events (FAERS/openFDA)#

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