Label: UP AND UP ALLERGY AND CONGESTION RELIEF- loratadine and pseudoephedrine sulfate tablet, extended release

  • NDC Code(s): 11673-013-39, 11673-013-60
  • Packager: Target Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 07/12

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?

    Call 1-800-910-6874

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  • Package/Label Principal Display Panel

    non-drowsy*

    allergy and congestion relief

    pseudoephedrine sulfate 120 mg/nasal decongestant

    loratadine 5 mg/antihistamine

    extended release tablets

    Compare to active ingredients in Claritin-D® 12 Hour

    original prescription strength

    indoor and outdoor allergies

    relief of:

    nasal and sinus congestion due to colds or allergies

    sneezing/runny nose/itchy, watery eyes/itchy throat or nose due to allergies

    *when taken as directed.

    see drug facts panel.

    12 HOUR

    TABLETS

    SHOWN ACTUAL SIZE ABOVE

    Allergy and Congestion Relief Carton Image 1

    Allergy and Congestion Relief Carton Image 1

    Allergy and Congestion Relief Carton Image 2

    Allergy and Congestion Relief Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    UP AND UP ALLERGY AND CONGESTION RELIEF 
    loratadine, pseudoephedrine tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-013
    Route of Administration ORAL DEA Schedule     
    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)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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:11673-013-60 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:11673-013-39 3 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076050 03/12/2012
    Labeler - Target Corporation (006961700)
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