Label: GOOD SENSE ALLERGY AND CONGESTION RELIEF- loratadine and pseudoephedrine sulfate tablet, film coated 

  • NDC Code(s): 0113-0165-22, 0113-0165-52
  • Packager: L Perrigo Company
  • 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 01/11

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

  • Active ingredient (in each tablet)

    Loratadine 10 mg

    Pseudoephedrine sulfate 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.

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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

    • store between 20ºC to 25ºC (68ºF to 77ºF)
    • protect from light and store in a dry place
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  • Inactive ingredients

    colloidal silicon dioxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, polyethylene oxide, {and} titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Non-Drowsy*

    Original Prescription Strength

    *When taken as directed. See Drug Facts Panel.

    Allergy & Congestion Relief

    Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

    Loratadine 10 mg/Antihistamine

    Extended Release Tablets

    Actual Size

    24 hour

    Relief of:

    Nasal & Sinus Congestion Due to Colds or Allergies

    Sneezing; Runny Nose; Itchy, Watery Eyes;

    Itchy Throat or Nose Due to Allergies

    Compare to active ingredients of Claritin-D® 24 Hour Tablets

    Allergy & Congestion Relief Carton Image 1

    Allergy & Congestion Relief Carton Image 1

    Allergy & Congestion Relief Carton Image 2

    Allergy & Congestion Relief Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    GOOD SENSE ALLERGY AND CONGESTION RELIEF 
    pseudoephedrine sulfate, loratadine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0113-0165
    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
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOL  
    POLYETHYLENE GLYCOL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE (Off-White) Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code L724
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0113-0165-52 2 in 1 CARTON
    1 5 in 1 BLISTER PACK
    2 NDC:0113-0165-22 3 in 1 CARTON
    2 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075989 06/22/2009
    Labeler - L Perrigo Company (006013346)
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