Label: CRANE SAFETY IBUPROFEN- ibuprofen tablet, coated

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

Drug Label Information

Updated July 8, 2021

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

  • Drug Facts

  • Active ingredient

    Ibuprofen 200 mg (*NSAID)

    *nonsteroidal antinflamatory drug

  • 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

    Heart attack or stroke warning:


    NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, asthma or had a stroke

    ■ 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

  • 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

    ■ you have 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 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 he 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?

    877.506.4291

  • Crane Safety Ibuprofen Label

    IBUPROFEN

    Pain Reliever/Fever Reducer (NSAID)

    CRANE Safety®

    Pull To Open

    This Package Is For Households Without Young Children.

    Ached, Fever

    Ibuprofen (NSAID) 200 mg

    100 Tablets

    Tamper Evident

    Sealed Packets

    C 1

  • Crane Safety Ibuprofen Label

    IBUPROFEN

    Pain Reliever/Fever Reducer (NSAID)

    CRANE Safety®

    Pull To Open

    This Package Is For Households Without Young Children.

    Ached, Fever

    Ibuprofen (NSAID) 200 mg

    100 Tablets

    Tamper Evident

    Sealed Packets

    C 2

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-709(NDC:47682-709)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-709-3350 in 1 BOX01/17/2020
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/17/2020
    CRANE SAFETY IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-609(NDC:47682-609)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-609-3350 in 1 BOX01/17/2020
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501001/17/2020
    Labeler - Crane Safety, LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(73408-609, 73408-709) , repack(73408-609, 73408-709)