Label: ARAMARK PAIN-FREE EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts


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

  • 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

  • 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

  • ASK DOCTOR

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

  • 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

  • WHEN USING

    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

  • 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 for 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
    6 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:
    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

    0560-2 100ct Box

    250 Tablet Box

    0560-3 250ct Box

    2-Tablet Packet

    0560 2ct Packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK PAIN-FREE EXTRA STRENGTH 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0560-250 in 1 BOX05/07/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-0560-3125 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(81238-0560)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION944090448manufacture(81238-0560)