Aramark Extra Strength Acetaminophen

Manufacturer
Western First Aid Safety DBA Aramark | ULTRA SEAL CORPORATION
Effective date
2021-07-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:38

Label at a glance#

ProductAramark Extra Strength Acetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient (in each tablet)
Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen ...................Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

Uses:
Temporarily Relieves minor aches and pains
due to:
• Headache, toothaches, menstrual cramps,
  the common cold,
• muscular aches, minor pain of arthritis
  Temporarily reduces fever

WARNINGS SECTION

Warnings:
Allergy Alert: Acetaminophen may cause a severe skin
reactions.
Symptoms may include:
• Skin reddening •Blisters •Rash
• If a skin reaction occurs, stop use and seek medical
  right away.

Liver Warning: This product contains an
acetaminophen. Severe liver damage may occur if you
take:
• more than 8 tablets in 24 hours, which is the
maximum daily amount
• 3 or more alcoholic drinks every day while using this
product

• take more or for a longer time than directed

OTC - DO NOT USE SECTION

Do not use:
• if you have ever had an allergic reaction to any
  other pain
• reliever/fever reducer
• right before or after heart surgery
• if you have ever had an allergic reaction to this
  product or any of its ingredients

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:
• under a doctor’s care for any serious condition
• taking the blood thinning drug Warfarin

OTC - WHEN USING SECTION

When using this product:
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if
  you use more than directed or for longer than
  directed

OTC - STOP USE SECTION

Stop use and ask a doctor if:
• pain gets worse lasts more than 10 days
• feel faint
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms occur

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. 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.

DOSAGE & ADMINISTRATION SECTION

Directions:
• do not take more than directed
• adults and children 12 years and over: take 2
  tablets every 4 to 6 hours as needed
• do not exceed 8 tablets in 24 hours, unless
  directed by a doctor
• Children under 12 years: Do not use this product

OTHER SAFETY INFORMATION

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

100 TABLETS        Part # 90433B
PER BOX

Extra Strength
Acetaminophen
Pain Reliever/Fever Reducer

Temporary relief of minor aches and
pains associated with a cold,
headache, tootache, muscular aches,
and for the reduction of fever

Compare active ingredient to:
Extra Strength Tylenol®
Registered Trademark of Johnson & Johnson

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
866-362-2691

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

100 ct 3500-1 Box100 ct 3500-1 Box

250 Tablet Box

250 ct 3500-2 Box250 ct 3500-2 Box

2-Tablet Packet

2ct 3500 Packet2ct 3500 Packet

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81238-3500-12023-01-30C16284748780-1f386c649-f4c1-0266-e053-dadaa90a7c1aAramark Extra Strength Acetaminophen
81238-3500-22023-01-30C16284748780-1f386c649-f4c1-0266-e053-dadaa90a7c1aAramark Extra Strength Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-3500-1Aramark Extra Strength Acetaminophen2 in 1 PACKETTABLET22
81238-3500-1Aramark Extra Strength Acetaminophen50 in 1 BOXTABLET502
81238-3500-2Aramark Extra Strength Acetaminophen125 in 1 BOXTABLET1252
81238-3500-2Aramark Extra Strength Acetaminophen2 in 1 PACKETTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-3500ARAMARK EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [WESTERN FIRST AID SAFETY DBA ARAMARK]2Legacy NDC, 4 package rows20211215_9bf4ca22-2546-4803-a199-b7d782e04a97.zip

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
81238-350081238-3500-1, 81238-3500-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
1114224d-5c96-43e0-aa89-bb7b1550be479bf4ca22-2546-4803-a199-b7d782e04a972021-07-19WarningsExact identifier
spl id: 1114224d-5c96-43e0-aa89-bb7b1550be47
spl set id: 9bf4ca22-2546-4803-a199-b7d782e04a97

Reported adverse events (FAERS/openFDA)#

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