FDA Label for Aramark Extra Strength Acetaminophen

View Indications, Usage & Precautions

Aramark Extra Strength Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Western First Aid Safety Dba Aramark. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts

Active Ingredient (in each tablet)
Acetaminophen 500 mg


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

res


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