Label: AEROTAB IBUPROFEN- ibuprofen tablet tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 29, 2022

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, backache, 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. If an allergic reaction occurs stop use an dseek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

  • ASK A DOCTOR BEFORE USE

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or frever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, had a stroke, you are taking a diuretic

    Ask a doctor or pharmacist before use if

    • you are under a doctor's care for any serious condition
    • Taking aspirin for a heart attack or stroke, because ibuprofen may decrease this benefit of asprin
    • taking any other drug

  • WHEN USING THIS PRODUCT

    When using this product take with food or milk if stomach upset occurs

  • STOP USE AND ASK A DOCTOR

    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
    • stomach pain that does not get better
    • symptoms of heart problems or stroke
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • pain gets worse or last more than 10 days
    • fever gets worse or last more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
  • IF PREGNANT 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.

    Overdose warning: In case of overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions: take only as directed - see Overdose warning.

    Adults and children 12 years of age and older 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 hoiurs, unless directed by a doctor.

    Children under 12 years ask a doctor. Do not take more than directed (see overdose warning). The smallest effective dose should be used.

  • OTHER INFORMATION

    Other Information

    Tamper evident. Do not use if packet is torn, cut or opened. Store between 20C to 25C (68F to 77F). Read all warnings and directions before use

  • INACTIVE INGREDIENTS

    Inactive Ingredients:

    corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

  • PRODUCT PACKAGE

    AeroTab

    Ibuprofen USP 200mg

    Anti-inflammatory

    Fever reducer

    Pain reliever

    250

    2 per packet

    50 Tablet Box100 Tablet Box250 Tablet Box2 Tablet Packet

  • INGREDIENTS AND APPEARANCE
    AEROTAB IBUPROFEN 
    ibuprofen tablet tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-133-0225 in 1 BOX01/01/2018
    1NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55305-133-0325 in 1 BOX01/01/2018
    2NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55305-133-0450 in 1 BOX01/01/2018
    3NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
    4NDC:55305-133-05125 in 1 BOX01/01/2018
    4NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123901/01/2018
    Labeler - Aero Healthcare (008186174)