Label: ARAMARK ASPIRIN- aspirin 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 May 19, 2021

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  • Drug Facts

    Active Ingredients

    (in Each Tablet)

    Aspirin USP (NSAID)*  325 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses: temporarily relieves minor pain
    due to: • headache • menstrual pain
    • minor pain of arthritis • muscle pain
    • pain and fever of colds • toothache
    • temporarily reduces fever

  • 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

    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

    Ask 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

    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 stools. These are signs of stomach
      bleeding.

    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:

    Take 2 tablets every 4
    to 6 hours as needed.
    Do not exceed 12 tablets
    in 24 hours or as directed
    by a doctor.
     • Children under
       12 years:    		Consult a doctor.

  • INACTIVE INGREDIENT

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

  • Product Package

    aramark

    Aspirin

    Part # 556R23

    100 TABLETS PER BOX

    Compare active ingredient to:
    BAYER®
    Registered Trademark of Bayer Corp.

    Retain carton for complete product information

    MANUFACTURED FOR:
    Aramark
    Lenexa, KS 66219
    (913) 269-9611

    Box

    0232 Box

    Packet

    0232 Packt

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 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
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code FR21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0232-250 in 1 BOX05/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/01/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(81238-0232)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448manufacture(81238-0232)
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