Label: CEDAPRIN - ibuprofen tablet

  • NDC Code(s): 0498-7500-01, 0498-7500-10, 0498-7500-25, 0498-7500-50
  • Packager: North Safety Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

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

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pains due to:
    headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis
    temporarily reduces fever

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  • 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 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 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 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 this benefit of aspirin 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 for 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 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 appear
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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    keep out of the 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 for children even if you do not notice any signs or symptoms.

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Corn Starch, DC yellow 10, FDC Blue 1, Microcrystalline Cellulose, Povidone, stearic acid

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  • PURPOSE

    Pain Reliever, Fever Reducer

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Ibuprofen 200 mg

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    MM1Cedaprin 500ct cartonEnter section text here

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  • INGREDIENTS AND APPEARANCE
    CEDAPRIN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0498-7500
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    SILICON DIOXIDE  
    POLYETHYLENE GLYCOL  
    CELLULOSE, MICROCRYSTALLINE  
    FD&C RED NO. 40  
    FD&C BLUE NO. 2  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    POLYDEXTROSE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color brown (CHOCOLATE BROWN) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code IBU;200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-7500-50 250 in 1 BOX
    1 NDC:0498-7500-25 125 in 1 BOX
    1 NDC:0498-7500-10 50 in 1 BOX
    1 NDC:0498-7500-01 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 03/07/2012
    Labeler - North Safety Products LLC (059980441)
    Registrant - North Safety Products LLC (059980441)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack
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