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  5. Label Information: Aramark Pain Free

FDA Label for Aramark Pain Free

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENT
    12. PRODUCT PACKAGE

Aramark Pain Free 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.

Drug Facts



Active Ingredient (in each tablet)
Pain Free Formula L242

Acetaminophen 110 mg
Aspirin (NSAID) 162 mg
Caffeine 32.4 mg
Salicylamide (NSAID) 152 mg


Otc - Purpose



Purpose

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


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 assocated
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
• 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
  • with any other product containing
    acetaminophen


Otc - Ask Doctor



Ask a doctor before using if you have:
• upset stomach or stomach pain • ulcers
• bleeding problems • high blood pressure • heart or
  kidney disease • taken a diuretic • reached age 60
  or older
Ask a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID
  (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or
  steroid drug
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
• you feel faint, vomit blood, or have bloody or
  black stoools.
• These are signs of stomach bleeding.


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 children
even if you do not notice any signs or symptoms.


Dosage & Administration



Directions:
• Adults and
   children 12 years
   of age and older:

2 tablets as

needed for pain
every 4 hours. Do
not exceed 8 tablets
in 24 hours or as
directed by a doctor.

 • Children under
   12 years:		Consult a doctor.


Other Safety Information



Other Information:
Tamper evident. Do not use if packet is
torn, cut or opened Store at controlled
room temperature 15° to 30°C (59° to 86° F)
Avoid excessive heat and humidity


Inactive Ingredient



Inactive Ingredients:
FD&C Yellow #6, Magnesium Stearate,
Microcrystalline Cellulose, Povidone, Starch,
Stearic Acid


Product Package



aramark

Pain-Free®

Extra Strength Pain Reliever

Temporary relief of minor
aches and pains associated with
a cold, headache, toothache and
muscular aches

Part # 537R23

100 TABLETS

PER BOX

Compare active ingredient to:

EXCEDRIN®
Registered Trademark of GlaxoSmithKline

Retain carton for complete product information

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

100 Tablet Box

250 Tablet Box

2-Tablet packet

res


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