Label: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated

  • NDC Code(s): 68016-423-21
  • Packager: Chain Drug Consortium, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/15

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

  • ACTIVE INGREDIENTS (IN EACH CAPLET)

    Ibuprofen, USP 200 mg (NSAID)*

    Pseudoephedrine HCl, USP 30 mg

    *nonsteroidal anti-inflammatory drug

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  • PURPOSES

    Pain reliever/Fever reducer

    Nasal decongestant

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  • USES

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

    fever
    sinus pressure
    nasal congestion
    headache
    minor body aches and pains
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  • 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).

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  • 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
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  • 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.
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  • 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

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  • QUESTIONS?

    Call 1-800-406-7984

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  • PRINCIPAL DISPLAY PANEL

    Premier Value®

    NDC68016-423-21

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

    Non-Drowsy

    Ibuprofen and Pseudoephedrine HCl Tablets, USP

    Cold & Sinus Formula

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

    *nonsteroidal anti-inflammatory drug

    Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant

    Relieves Sinus Pressure, Nasal Congestion and Fever

    20 COATED CAPLETS

    Oval-Shaped Tablets

    DISTRIBUTED BY CHAIN DRUG CONSORTIUM

    5097029/R0712

    This is the 20 count blister carton label for Ibuprofen & Pseudoephedrine HCl  tablets, USP.
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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-423
    Route of Administration ORAL DEA Schedule     
    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
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    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)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color brown Score no score
    Shape OVAL (Caplets) Size 14mm
    Flavor Imprint Code 423
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-423-21 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074567 10/13/2001
    Labeler - Chain Drug Consortium, LLC. (101668460)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 MANUFACTURE(68016-423)
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