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

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 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 LABEL Item Code (Source) NDC:11673-013
    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  
    POVIDONE  
    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: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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