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

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

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

    Close
  • PURPOSES

    Pain reliever/Fever reducer

    Nasal decongestant

    Close
  • USES

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

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

    Close
  • 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
    Close
  • 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.
    Close
  • 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

    Close
  • QUESTIONS?

    Call 1-800-406-7984

    Close
  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients of Advil®Cold & Sinus

    NDC 51660-490-41

    Non-Drowsy

    Cold & Sinus Relief

    Ibuprofen and Pseudoephedrine HCl Tablets, USP

    IBUPROFEN, USP 200 mg · PAIN RELIEVER/FEVER REDUCER (NSAID)*

    PSEUDOEPHEDRINE HCl, USP 30 mg · NASAL DECONGESTANT

    *nonsteroidal anti-inflammatory drug

    Relieves Sinus Pressure, Nasal Congestion and Fever

    40 Coated Caplets**(**oval-shaped tablets)

    Distributed by: Ohm Laboratories Inc.

    5089900/0911

    This is the 40 count blister carton label for Walmart Ibuprofen and Pseudoephedrine HCl tablets, USP.
    Close
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51660-490
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GUAR GUM  
    TRISTEARIN  
    HYDROXYPROPYL CELLULOSE  
    FERROSOFERRIC OXIDE  
    KAOLIN  
    POLYETHYLENE GLYCOLS  
    POWDERED CELLULOSE  
    POVIDONE  
    STARCH, PREGELATINIZED CORN  
    PROPYLENE GLYCOL  
    SHELLAC  
    SILICON DIOXIDE  
    SODIUM BENZOATE  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    WHITE WAX  
    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:51660-490-41 40 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074567 10/13/2001
    Labeler - Ohm Laboratories Inc. (184769029)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(51660-490)
    Close