Label: LORATADINE D- loratadine and pseudoephedrine sulfate tablet, extended release 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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

  • 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

    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. (1-800-222-1222)

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  • Directions

    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

    each tablet contains: calcium 25 mg
    do not use if blister unit is broken or torn
    store between 20° to 25°C (68° to 77°F)
    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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  • PRINCIPAL DISPLAY PANEL

    Pseudoephedrine/Loratadine 120mg/ 5mg

    Label
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  • INGREDIENTS AND APPEARANCE
    LORATADINE D 
    loratadine, pseudoephedrine tablet, extended release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4790(NDC:45802-106)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 5 mg
    PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POVIDONES  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4790-1 14 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076050 01/19/2012
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4790), RELABEL(63629-4790)
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