FDA Label for Aramark Pain-free Extra Strength

Otc - Active Ingredient

Drug Facts

Extra Strength Pain Reliever M560L
Active Ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID) 250 mg
Caffeine 65 mg

Otc - Purpose

Acetaminophen ....Pain Reliever/Fever Reducer
Aspirin (NSAID) ....Pain Reliever/Fever Reducer
Caffeine ...............Adjuvent

Indications & Usage

Uses:
Temporarily Relieves minor aches and pains
associated with: • backach • headaches
• colds • toothache • minor arthritis pain
• muscular aches • menstrual cramps

Warnings

Warnings:
• Reye’s Syndrome: Children and teenagers should not
  use this medicine for chicken pox or flu symptoms
  before a doctor is consulted about Reye’s Syndrome,
  a rare but serious illness reported to be associated
  with aspirin.
• Allergy Alert - Do not use:
   • if you are allergic to aspirin or any other salicylate
   • if you have ever had an allergic reaction to any
  other pain reliever/fever reducer
• Liver Warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
   • more than 8 tablets in 24 hours
   • with other drugs containing acetaminophen
     (Prescription or nonprescription)
   • Ask a doctor or pharmacist before using with
     other drugs if you are not sure.
   • 3 or more alcoholic drinks every day while
      using this product.
• Stomach Bleeding Warning: This product contains
  nonsteroidal anti-inflammatory drugs (NSAIDs),
  which may cause stomach bleeding. The chance is
  higher if you:
   • are age 60 or older
   • have had stomach ulcers or bleeding problems
   • take a blood thinning (anticoagulant) or steroid
     drug
   • take other drugs containing an NSAID (aspirin,
      ibuprofen, naproxen, or others)
   • take more or for a longer time than directed

Otc - Do Not Use

• Do not use:

   • with any other pain reliever/fever reducer
   • for pain for more than 10 days or for fever for
     more than 3 days unless directed by a doctor
   • if you have ever had an allergic reaction to
     any other pain reliever/fever reducer

Otc - Ask Doctor

Ask a doctor before using if you have:
• upset stomach or stomach pain • gastric ulcers
• bleeding problems • asthma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
taking a prescription drug for:
• anticoagulation (thinning of blood)
• gout
• diabetes
• arthritis

Otc - When Using

When using this product do not exceed the
recommended dose.

Otc - Stop Use

Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health
professional before use. IT IS ESPECIALLY
IMPORTANT NOT TO USE ASPIRIN DURING THE
LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR
BECAUSE IT MAY CAUSE PROBLEMS IN THE
UNBORN CHILD OR COMPLICATIONS DURING
DELIVERY.

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

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:
Hydroxypropyl Methylcellulose, Microcrystalline
Cellulose, Polyethylene Glycol, Povidone, Sodium
Starch Glycoate, Stearic Acid, Titanium Dioxide

Package Labeling

aramark

100 TABLETS        Part # 547R23
PER BOX

Pain-Free^® Extra Strength
Maximum Strength
Pain Reliever

Temporary relief of fever and
the pain of Sinusitis, headache,
toothache, muscular aches,
backache, menstrual discomfort,
minor arthritis pain and colds
and flu.

Compare active ingredient to:
EXCEDRIN Migraine^®
Registered Trademark of GlaxoSmithKline

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

250 Tablet Box

2-Tablet Packet

res