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

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  • 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, USP 10 mg

    Pseudoephedrine sulfate, USP 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 (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 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

    • sodium: contains 10 mg/tablet
    • calcium: contains 25 mg/tablet
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister carton/label)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle carton/label)
    • store between 20° C to 25° C (68° F to 77° F)
    • protect from light and store in a dry place
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  • INACTIVE INGREDIENTS

    calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

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  • QUESTIONS?

    call 1-800-406-7984

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  • PRINCIPAL DISPLAY PANEL

    Loratadine/psuedoephedrine 24 Hour tab

    Label
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  • INGREDIENTS AND APPEARANCE
    LORATADINE AND PSEUDOEPHEDRINE 
    loratadine and pseudoephedrine tablet, extended release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-1330(NDC:51660-724)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 10 mg
    PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    SILICON DIOXIDE  
    HYDROXYPROPYL CELLULOSE  
    HYPROMELLOSES  
    FERROSOFERRIC OXIDE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    STARCH, CORN  
    PROPYLENE GLYCOL  
    SHELLAC  
    SODIUM ALGINATE  
    SODIUM CITRATE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code RX724
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-1330-1 14 in 1 BOTTLE
    2 NDC:63629-1330-2 5 in 1 BOTTLE
    3 NDC:63629-1330-3 10 in 1 BOTTLE
    4 NDC:63629-1330-4 15 in 1 BOTTLE
    5 NDC:63629-1330-5 30 in 1 BOTTLE
    6 NDC:63629-1330-6 60 in 1 BOTTLE
    7 NDC:63629-1330-7 20 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076557 11/17/2004
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-1330), RELABEL(63629-1330)
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