Label: FIRST AID ONLY IBUPROFEN- ibuprofen tablet, coated

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

Drug Label Information

Updated November 4, 2019

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

  • Active ingredient

    Ibuprofen 200 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Drug Facts

  • Purpose

    Pain reliever/fever reducer

  • Uses

    Temporarily relieves minor aches and pains associated with

    ■ headache ■ toothache ■ backache ■ menstrual cramps

    ■ common cold ■ muscular aches ■ minor arthritis pain

    Temporarily reduces fever.

  • Warnings

  • Allergy Alert:

    Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    ■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

  • 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 or nonprescription 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

    ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

    ■ right before or after heart surgery

  • Ask a doctor before use if

    ■ you have problems or serious side effects from taking pain relievers or fever reducers

    ■ stomach bleeding warning applies to you

    ■ you have a history of stomach problems such as heartburn

    ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    ■ you have asthma

    ■ you are taking a diuretic

  • Ask a doctor or pharmacist before use if you are

    ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

    ■ under a doctor’s care for any serious condition

    ■ taking any other drug

  • 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 longer than directed

  • 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 for more than 10 days

    ■ fever gets worse or lasts for more than 3 days

    ■ redness or swelling is present in the painful area

    ■ any new or unexpected symptoms occur

  • 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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    do not use more than directed

    the smallest effective dose should be used

    ■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

    Adults and children:(12 years 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 hours, unless directed by a doctor.

    Children under 12 years:

    Do not give to children under 12 years of age.

  • Other information

    ■ read all product information before using

    ■ store at 68-77°F (20-25°C)

    ■ avoid excessive heat 40°C (above 104°F)

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • Inactive ingredients

    carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

    *may contain

  • Questions or comments?

    1-800-835-2263

  • First Aid Only Ibuprofen Label

    First Aid Only Ibuprofen Carton

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0275(NDC:47682-600)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0275-0120 in 1 BOX, UNIT-DOSE01/26/2017
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501002/01/2016
    Labeler - Acme United Corporation (001180207)
    Registrant - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0275) , repack(0924-0275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0275) , repack(0924-0275)