Label: ARAMARK IBUPROFEN- ibuprofen tablet

  • NDC Code(s): 81238-0103-1, 81238-0103-2
  • Packager: Western First Aid Safety DBA Aramark
  • 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 20, 2021

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient (in each tablet)
    ​Ibuprofen 200 mg (NSAID)*

  • PURPOSE

    Purpose
    Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

    *nonsteroidal anti-inflammatory drug

  • INDICATIONS & USAGE

    Uses:
    Temporarily Relieves minor aches and pains
    due to:
    • Headache, toothaches, menstrual cramps,
      the common cold,
    • muscular aches, minor pain of arthritis
      Temporarily reduces fever

  • WARNINGS

    Warnings:

    Allergy Alert: Ibuprofen may cause a severe allergic
    reaction, especially in people allergic to aspirin.
    Symptoms may include:
    • hives, facial swelling, asthma (wheezing), shock,
      skin reddening, rash, blisters

    Stomach bleeding warning: This product contains an
    NSAID, which may cause severe 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 prescription NSAIDs
      (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while
      using this product
    • take more or for a longer time than directed

  • DO NOT USE

    Do not use:
    • if you have ever had an allergic reaction to any
      other pain
    • reliever/fever reducer
    • right before or after heart surgery
    • if you have ever had an allergic reaction to this
      product or any of its ingredients

  • ASK DOCTOR

    Ask a doctor before use if:
    • stomach bleeding warning applies to you
    • you have problems or serious side effects from
      taking pain
    • relievers or fever reducers
    • you have a history of stomach problems, such
      as heartburn
    • you have high blood pressure, heart disease, liver
      cirrhosis, kidney disease, or asthma
    • you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attack or stroke, because
      ibuprofen may decrease the benefit of aspirin
    • taking the blood thinning drug Warfarin

  • WHEN USING

    When using this product:
    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if
      you use more than directed or for longer than
      directed

  • STOP USE

    Stop use and ask a doctor if:
    • you experience any of the following signs of
       stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the
      painful area
    • any new symptoms occur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health
    professional before use. It is especially important
    not to use ibuprofen during the last 3 months of
    pregnancy unless definitely 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.

  • DOSAGE & ADMINISTRATION

    Directions:
    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 tablet
      every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet,
      2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless
      directed by a doctor
    • children under 12 years: ask 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:
    colloidal silicon dioxide, corn starch, sodium starch
    glycollate, hypromellose, lactose monohydrate,
    povidone, pregelatinized corn starch, red iron oxide,
    sodium starch glycolate, steric acid, talc, titanium
    dioxide, triacetin, purified water

  • Product Package

    aramark

    100 TABLETS PER BOX            Part # 552R23

    Ibuprofen
    Anti-Inflammatory Fever
    Reducer

    Compare active ingredient to:

    ADVIL®
    Registered Trademark of Pfizer Consumer Healthcare

    Retain carton for complete product information

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

    aramarkuniform.com

    100 Tablet Box

    0103 100 Tab Box

    250 Tablet Box

    0103 250 Tab Box

    2-Tablet Packet

    0103 2-Tab Packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE (UNII: FZ989GH94E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize15mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0103-150 in 1 BOX05/14/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-0103-2125 in 1 BOX05/14/2021
    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 finalpart34305/14/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(81238-0103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448manufacture(81238-0103)