Label: 12 HOUR ALLERGY AND CONGESTION- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 0363-1133-46, 0363-1133-60, 0363-1133-65
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 22, 2019

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  • Active ingredients (in each tablet)

    Loratadine 5 mg

    Pseudoephedrine sulfate 120 mg

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  • Purpose

    Antihistamine

    Nasal decongestant

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  • Uses

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

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  • Do not use

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    if you have ever had an allergic reaction to this product or any of its ingredients
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    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.
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  • Ask a doctor before use if you have

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    heart disease
    •
    thyroid disease
    •
    high blood pressure
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    diabetes
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    trouble urinating due to an enlarged prostate gland
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    liver or kidney disease. Your doctor should determine if you need a different dose.
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  • When using this product do not take more than directed.

    Taking more than directed may cause drowsiness.

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  • Stop use and ask a doctor if

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

    ask a health professional before use.

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  • 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

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    do not divide, crush, chew or dissolve the tablet

    adults and children 12 years and over

    1 tablet every 12 hours; not more than 2 tablets 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

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    each tablet contains: calcium 25 mg
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    do not use if blister unit is broken or torn
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    store between 20° to 25°C (68° to 77°F)
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    keep in a dry place
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  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    NON-DROWSY*

    Wal-itin® D

    Compare to Claritin-D® 12 Hour Tablets active ingredients

    12 HOUR ALLERGY & CONGESTION

    PSEUDOEPHEDRINE SULFATE 120 mg / NASAL DECONGESTANT

    LORATADINE 5 mg / ANTIHISTAMINE

    EXTENDED-RELEASE TABLETS

    12 HOUR - EXTENDED RELEASE TABLETS

    INDOOR & OUTDOOR ALLERGIES

    12-hour relief of: nasal & sinus congestion due to colds or allergies; sneezing; runny nose; itchy, watery eyes & itchy throat or nose due to allergies

    30 EXTENDED-RELEASE TABLETS

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    12 HOUR

    ACTUAL SIZE

    walitin d image
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  • INGREDIENTS AND APPEARANCE
    12 HOUR ALLERGY AND CONGESTION 
    loratadine, pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1133
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (to off-white) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code 7U0
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-1133-46 10 in 1 CARTON 05/05/2018
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0363-1133-60 20 in 1 CARTON 05/05/2018
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0363-1133-65 30 in 1 CARTON 05/05/2018
    3 1 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 ANDA076050 05/05/2018
    Labeler - Walgreen Company (008965063)
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