IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]

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IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]
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NDC 63868-453-20
Set ID 093e6388-54f2-4d04-ba55-8f7c9c182a0e
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA074567
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  • ACTIVE INGREDIENTS (IN EACH CAPLET)

    Ibuprofen, USP 200 mg (NSAID)*

    Pseudoephedrine HCl, USP 30 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSES

    Pain reliever/Fever reducer

    Nasal decongestant

  • 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

    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

    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, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
    • 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 any other drug
    • taking any other product that contains pseudoephedrine or any other nasal decongestant
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

    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
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • symptoms continue or get worse
    • any new symptoms appear
    • you get nervous, dizzy, or sleepless
    • fever gets worse or lasts more than 3 days
    • nasal congestion lasts for more than 7 days
    • redness or swelling is present in the painful area

    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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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 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
  • OTHER INFORMATION

    • store at 20 - 25○ C (68 - 77○ F). Avoid excessive heat above 40○ C (104○ F).
    • read all warnings and directions before use. Keep carton.
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • INACTIVE INGREDIENTS

    Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    QC QUALITY CHOICE®

    NDC 63868-453-20

    *Compare to the active ingredients in Advil®Cold & Sinus

    NON-DROWSY

    IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP

    Cold & Sinus Formula

    Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID)٭

    Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant

    FOR RELIEF OF:

    • Sinus Pressure
    • Nasal Congestion
    • Fever

    20 COATED CAPLETS†(†Oval-Shaped Tablets)

    ٭nonsteroidal anti-inflammatory drug

    ©DISTRIBUTED BY QUALITY CHOICE

    5089124/R0811

    This is the 20 count blister carton label for Quality Choice Ibuprofen and Pseudoephedrine HCl Tablets, USP.

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-453
    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
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GUAR GUM (UNII: E89I1637KE)  
    TRISTEARIN (UNII: P6OCJ2551R)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVAL (Caplets) Size14mm
    FlavorImprint Code 423
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-453-2020 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07456710/13/2001
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(63868-453)
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