Label: ARAMARK PAIN FREE- acetaminophen, aspirin, caffeine, salicylamide tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 3, 2021

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  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • 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

    0242 100Tab Box

    250 Tablet Box

    0242 250 Tab Box

    2-Tablet packet

    0242 2-Tab Packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK PAIN FREE 
    acetaminophen, aspirin, caffeine, salicylamide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0242-150 in 1 BOX05/07/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-0242-2125 in 1 BOX05/07/2021
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/07/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)