Label: LORATADINE AND PSEUDOEPHEDRINE SULFATE tablet, film coated, extended release

  • NDC Code(s): 41250-724-52, 41250-724-69
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 5, 2021

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

  • 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
    reduces swelling of nasal passages
    temporarily relieves sinus congestion and pressure
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    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

    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.
    store between 20° C to 25° C (68° F to 77° F).
    protect from light and store in a dry place
  • 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

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    NDC 41250-724-69

    Compare to CLARITIN-D®24 HOUR active ingredients**

    meijer

    Original Prescription Strength

    Non-Drowsy*

    24 HOUR

    Allergy Relief & Nasal Decongestant

    Loratadine, USP 10 mg · Antihistamine

    Pseudoephedrine Sulfate, USP 240 mg · Nasal Decongestant

    Indoor & Outdoor Allergies

    Relief of:

    sneezing; runny nose; itchy, watery eyes;

    itchy throat or nose due to allergies

    nasal & sinus congestion due to colds or allergies

    *When taken as directed.

    See Drug Facts Panel.

    10 EXTENDED-RELEASE TABLETS

    DIST. BY MEIJER DISTRIBUTION, INC.

    5079439/R0710

    This is the 10 count blister carton label for Meijer Loratadine D tablets.
  • INGREDIENTS AND APPEARANCE
    LORATADINE AND PSEUDOEPHEDRINE SULFATE 
    loratadine and pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-724
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White to Off-white) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-724-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
    2NDC:41250-724-5215 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655711/17/2004
    Labeler - Meijer Distribution, Inc. (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(41250-724)