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IBUPROFEN COLD AND SINUS (A P J Laboratories Limited)

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TABLET, COATED 20 TABLET, COATED in 1 BLISTER PACK (46084-091-60) Label Information

Complete IBUPROFEN COLD AND SINUS Information

  • ACTIVE INGREDIENT

    IBUPROFEN

    PSEUDOEPHEDRINE HYDROCHLORIDE


  • PURPOSE

    Pain reliever/Fever reducer

    Nasal decongestant





  • 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).


  • uses

    temporarily relieves these symptoms associated with the common cold or flu:

    fever

    sinus pressure

    nasal congestion

    headache

    minor body aches and pains




  • 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





  • DOSAGE & ADMINISTRATION

    do not take more than directed

    the smallest effective dose should be used.

    adults and children 12 years of age and over:

    take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.

    do not use more than 6 caplets in any 24-hour period unless directed by a doctor.

    children under 12 years of age: do not use.


  • DO NOT USE

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

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    in children under 12 years of age

    right before or after heart surgery


  • INACTIVE INGREDIENT

    CALCIUM CARBONATE

    STARCH, CORN

    METHYLPARABEN

    PROPYLPARABEN

    SODIUM STARCH GLYCOLATE TYPE A POTATO

    TALC

    MAGNESIUM STEARATE

    SILICON DIOXIDE

    CROSCARMELLOSE SODIUM

    SODIUM LAURYL SULFATE

    ISOPROPYL ALCOHOL

    METHYLENE CHLORIDE

    TITANIUM DIOXIDE


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN COLD AND SINUS  A P J
    ibuprofen, pseudoephedrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-091
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) 20 mg
    STARCH, CORN (UNII: O8232NY3SJ) 8 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) .5 mg
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .2 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 6 mg
    TALC (UNII: 7SEV7J4R1U) 4 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 3 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 1.5 mg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1 mg
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 60 mg
    METHYLENE CHLORIDE (UNII: 588X2YUY0A) 150 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.5 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 15mm
    Flavor Imprint Code 091
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-091-60 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074567 06/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories Limited 677378339 manufacture(46084-091)