IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED]

IBUPROFEN COLD AND SINUS A P J (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [A P J LABORATORIES LIMITED]
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NDC 46084-091-60
Set ID db492dad-ab1c-459d-842c-062e4b3f4c57
Category HUMAN OTC DRUG LABEL
Packager A P J Laboratories Limited
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA074567
  • 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

  • PRINCIPAL DISPLAY PANEL

    product

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN COLD AND SINUS  A P J
    ibuprofen, pseudoephedrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-091
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeROUNDSize15mm
    FlavorImprint Code 091
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-091-6020 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07456706/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-091)

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