Ibuprofen and Pseudoephedrine Hydrochloride

Ibuprofen and Pseudoephedrine Hydrochloride

Drug Labeling and Warnings

Drug Details

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IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE- ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated 
The Kroger Company

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Ibuprofen and Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each caplet)Purposes
  • * nonsteroidal anti-inflammatory drug
  • Ibuprofen, USP 200 mg (NSAID)*Pain reliever/fever reducer
    Pseudoephedrine HCl, USP 30 mgNasal decongestant

    Uses

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

    • headache
    • fever
    • sinus pressure
    • nasal congestion
    • 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

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • in children under 12 years of age
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
    • 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.

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

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • fever gets worse or lasts more than 3 days
    • nasal congestion lasts for more than 7 days
    • symptoms continue or get worse
    • redness or swelling is present in the painful area
    • you get nervous, dizzy, or sleepless
    • any new symptoms appear

    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.

    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

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202

    PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton

    COMPARE TO the active ingredients of ADVIL® COLD & SINUS
    ***See side panel

    NDC: 30142-423-41

    NON-DROWSY

    See New Warnings Information

    Kroger®

    FROM OUR FAMILY
    TO YOURS

    Ibuprofen Cold & Sinus

    Ibuprofen and Pseudoephedrine HCl Tablets, USP
    Ibuprofen, USP 200 mg
    Pain Reliever/Fever Reducer (NSAID)*
    Pseudoephedrine HCl, USP 30 mg, Nasal Decongestant

    Relieves:

    • Sinus Pressure
    • Nasal Congestion
    • Fever

    *nonsteroidal anti-inflammatory drug

    40
    COATED CAPLETS**

    **oval-shaped tablets

    Our Pharmacists
    Recommend

    actual size

    PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton
    IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-423
    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 (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GUAR GUM (UNII: E89I1637KE)  
    GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVAL (Caplets) Size14mm
    FlavorImprint Code 423
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 30142-423-411 in 1 CARTON10/13/2001
    140 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07456710/13/2001
    Labeler - The Kroger Company (006999528)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(30142-423)

    Revised: 5/2018
     
    The Kroger Company


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