Otc - Active Ingredient
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Aramark Extra Strength Acetaminophen
FDA Label NDC 81238-3500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Aramark Extra Strength Acetaminophen (NDC 81238-3500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acetaminophen ...................Pain Reliever/Fever Reducer
Indications & Usage
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
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
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
Ask a doctor before use if:
• you have liver disease
Otc - Ask Doctor/Pharmacist
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
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
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
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
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
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
Inactive Ingredients:
Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid
Package Labeling
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
250 Tablet Box
2-Tablet Packet
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