FDA.reportPublic FDA data

Uline Acetaminophen Extra Strength

Manufacturer
Uline | Unifirst First Aid Corporation
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:13:16

Label at a glance#

ProductUline Acetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure18 sections

Indications and uses

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

Dosage and administration

do not use more than directed (see overdose warning) Adults and children: (12 years and over) Take 2 tablets every 6 while symptoms last. Do not take more than 6 tablets in 24 hours, unles directed by a doctor. Do not use for more than 10 days unless directed by a doctor. Children under 12 years: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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:

  • headache
  • muscular aches
  • minor arthritis pain
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

Temporarily reduces fever.

WARNINGS SECTION

Warnings

Liver warning:

SPL UNCLASSIFIED SECTION

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

  • more than 4,000 mg 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:

SPL UNCLASSIFIED SECTION

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.

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • liver disease

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts for 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 use more than directed (see overdose warning)

Adults and children: (12 years and over)

Take 2 tablets every 6 while symptoms last. Do not take more than 6 tablets in 24 hours, unles 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

OTHER SAFETY INFORMATION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

* May contain

Questions or comments?

OTC - QUESTIONS SECTION

1-800-295-5510

Uline Acetaminophen Extra Strength Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULINE

Tamper evident sealed packets:

Do not use if packet is open or torn.

This package is for households without young children

Acetaminophen

Pull to Open

Extra Strength

500 mg

• Pain Reliever

• Fever Reducer

50 Packets

2 tablets Each

175R S-18593BX 11-6-23 Label 1175R S-18593BX 11-6-23 Label 1

Uline Acetaminophen Extra Strength Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULINE

Tamper evident sealed packets:

Do not use if packet is open or torn.

This package is for households without young children

Acetaminophen

Pull to Open

Extra Strength

500 mg

• Pain Reliever

• Fever Reducer

50 Packets

2 tablets Each

175R S-18593BX 11-6-23 Label 2175R S-18593BX 11-6-23 Label 2

Uline Acetaminohen Extra Strength Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULINE

Tamper evident sealed packets:

Do not use if packet is open or torn.

This package is for households without young children

Acetaminophen

Pull to Open

Extra Strength

500 mg

• Pain Reliever

• Fever Reducer

50 Packets

2 tablets Each

175R S-18593BX 11-6-23 Label 3175R S-18593BX 11-6-23 Label 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULINE

Tamper evident sealed packets:

Do not use if packet is open or torn.

This package is for households without young children

Acetaminophen

Pull to Open

Extra Strength

500 mg

• Pain Reliever

• Fever Reducer

50 Packets

2 tablets Each

175R Uline Acetaminophen XS Uline 11-28-22175R Uline Acetaminophen XS Uline 11-28-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN8
198440acetaminophen 500 MG Oral TabletSCD8
198440APAP 500 MG Oral TabletSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69790-126-33Uline Acetaminophen Extra Strength2 in 1 PACKETTABLET, FILM COATED28
69790-126-33Uline Acetaminophen Extra Strength50 in 1 BOXTABLET, FILM COATED508
69790-154-33Uline Acetaminophen Extra Strength2 in 1 PACKETTABLET, FILM COATED28
69790-154-33Uline Acetaminophen Extra Strength50 in 1 BOXTABLET, FILM COATED508
69790-173-33Uline Acetaminophen Extra Strength2 in 1 PACKETTABLET, FILM COATED28
69790-173-33Uline Acetaminophen Extra Strength50 in 1 BOXTABLET, FILM COATED508
69790-804-33Uline Acetaminophen Extra Strength50 in 1 BOXTABLET, FILM COATED508
69790-804-33Uline Acetaminophen Extra Strength2 in 1 PACKETTABLET, FILM COATED28

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69790-17369790-173-33
69790-80469790-804-33
69790-12669790-126-33
69790-15469790-154-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSES3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
HYPROMELLOSES3NXW29V3WOIACT
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
POVIDONE K30U725QWY32XIACT
HYPROMELLOSES3NXW29V3WOIACT

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
Uline Acetaminophen Extra StrengthACETAMINOPHENUline90167594-0a49-2492-e053-2a95a90a14012025-09-09WarningsExact identifier
ndc (package): 69790-154-33
ndc (package): 69790-126-33
ndc (package): 69790-173-33
ndc (package): 69790-804-33
ndc (product): 69790-154
ndc (product): 69790-173
ndc (product): 69790-126
ndc (product): 69790-804
ndc11 (package): 69790017333
ndc11 (package): 69790012633
ndc11 (package): 69790080433
ndc11 (package): 69790015433
spl id: 3e5d8ade-be5f-4cfa-e063-6394a90a99f6
spl set id: 90167594-0a49-2492-e053-2a95a90a1401

Reported adverse events (FAERS/openFDA)#

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