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

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

Drug Label Information

Updated February 27, 2024

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  • Active ingredients (in each tablet)

    Loratadine 10 mg

    Pseudoephedrine sulfate 240 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • 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
  • 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).

  • 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
  • Other information

    •
    do not use if printed blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from light and store in a dry place
  • Inactive ingredients

    colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide

  • Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredients of CLARITIN-D® 24 HOUR

    See bottom panel

    Kroger®

    OUR PHARMACIST RECOMMENDED

    Non-Drowsy*

    Allergy & Congestion Relief

    ACTUAL SIZE

    RELIEF OF:

    Nasal & Sinus

    Congestion Due to Colds or Allergies;

    Pseudoephedrine Sulfate 240 mg

    Nasal Decongestant

    Sneezing; Runny Nose; Itchy, Watery Eyes;

    Itchy Throat or Nose Due to Allergies

    Loratadine 10 mg

    Antihistamine

    Extended Release Tablets

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    15 EXTENDED-RELEASE TABLETS

    *When taken as directed. See Drug Facts Panel.

    2d8-45-allergy-and-congestion-relief
  • INGREDIENTS AND APPEARANCE
    ALLERGY CONGESTION RELIEF 
    loratadine, pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-846
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-846-2215 in 1 CARTON02/22/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07598902/22/2024
    Labeler - Kroger Company (006999528)
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