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Pill Identifier Information of Proprinal 200 MG Oral Tablet

Drug Information

Proprinal 200 MG Oral Tablet

Imprint: P
Shape: C48348
Color: C48325
Ingredients: Ibuprofen
Size: 11.00
Score: 1
Rxtty: SY
Author: NorMed
Inactive Ingredients: CROSCARMELLOSE SODIUM / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOLS / POLYSORBATE 80 / POVIDONE / SILICON DIOXIDE / STEARIC ACID / TITANIUM DIOXIDE>

Complete Information

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer


  • INDICATIONS & USAGE

    Temporarily  relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor arthritis pain
    • the common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever

  • WARNINGS

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

    • hives
    • rash
    • shock
    • facial swelling
    • asthma (wheezing)
    • skin reddening
    • 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 more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcohol drinks every day while using this product
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)


  • 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


  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist if you are

    • unders a doctor's care for any serious condition
    • taking any other drug containing an NSAID
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking aspirin for heart attack or stroke (ibuprofen may decrease the benefit of aspirin)



  • WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke
  • STOP USE


    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • fever gets worse or lasts more than 3 days
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area.
    • new symptoms occur
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
  • 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. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions: do not take more than directed; the smallest effective dose should be used. Adults and children 12 years of age 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 take more than 6 tablets in 24 hours unless directed by a doctor

    children under 12 years of age: ask a doctor


  • PURPOSE

    Ibuprofen...to reduce pain and fever

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Carnauba Wax, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Clycolate, Stearic Acid, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

    5691 Proprinal 11s.jpg
  • INGREDIENTS AND APPEARANCE
    PROPRINAL 
    ibuprofen tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ibuprofen (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) ibuprofen200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0109-4100 in 1 BOX, UNIT-DOSE
    2NDC:50332-0109-7250 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/1990
    Labeler - NorMed (069560969)
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