Label: WAL ITIN D NON DROWSY- pseudoephedrine sulfate and loratadine tablet, extended release 

  • Label RSS
  • NDC Code(s): 0363-0165-13, 0363-0165-22, 0363-0165-52
  • Packager: Walgreen Company
  • 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 06/09

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

  • Active ingredient (in each tablet)

    Loratadine 10 mg

    Pseudoephedrine sulfate 240 mg

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  • Purpose

    Antihistamine

    Nasal decongestant

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  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itching of the nose or throat
    • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
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  • Warnings

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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 you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    do not take more than directed.

    Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

    • an allergic reaction to this product occurs. Seek medical help right away.
    • symptoms do not improve within 7 days or are accompanied by a fever
    • nervousness, dizziness or sleeplessness occurs

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not divide, crush, chew or dissolve the tablet
    adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
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  • Other information

    • do not use if blister unit is broken or torn
    • store between 20º to 25ºC (68º to 77ºF)
    • protect from light and store in a dry place
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  • Inactive ingredients

    black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide

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  • Questions or comments?  

    1-800-719-9260

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  • Principal Display Panel

    Compare to Claritin-D® 24 Hour active ingredients

    Non-Drowsy*

    24 Hour

    Wal-itin® D

    Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

    Loratadine 10 mg/Antihistamine

    Allergy & Congestion Relief

    Relief of: Nasal & Sinus Congestion due to Colds or Allergies

    Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose due to Allergies

    Tablets

    Actual Size

    *When taken as directed. See Drug Facts Panel.

    Wal-itin D Carton Image 1

    Wal-itin D Carton Image 1

    Wal-itin D Carton Image 2

    Wal-itin D Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    WAL ITIN D  NON DROWSY
    loratadine, pseudoephedrine sulfate tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0165
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 240 mg
    LORATADINE (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    CANDELILLA WAX  
    SILICON DIOXIDE  
    GLYCERYL MONOSTEARATE  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOL  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE (to off white) Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code Andrx;605
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0165-13 1 in 1 CARTON
    1 5 in 1 BLISTER PACK
    2 NDC:0363-0165-52 2 in 1 CARTON
    2 5 in 1 BLISTER PACK
    3 NDC:0363-0165-22 3 in 1 CARTON
    3 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075706 06/04/2003
    Labeler - Walgreen Company (008965063)
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