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

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

Drug Label Information

Updated May 27, 2025

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

  • Active ingredient (in each capsule)

    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

    • 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 enlarged prostrate 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 (1-800-222-1222) right away.

  • 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

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

    black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, propylene glycol, shellac

  • Questions or comments?

    call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER CARTON FOR COMPLETE

    WARNINGS AND PRODUCT INFORMATION

    THIS PRODUCT IS PACKAGED IN A CHILD-RESITANT AND TAMPER EVIDENT PACKAGE.

    Do not use if individual blister unit is open or torn.

    This product is not manufactured or distributed by the

    owners of Claritin-D® 24 hour

    MADE WITH PRIDE AND CARE FOR

    H-E-B® , SAN ANTONIO, TX 78204

    100%

    GUARANTEE

    promise

    If you aren't completely pleased

    with this product, we'll be happy to

    replace it or refund your money.

    You have our word on it.

    PRODUCT OF INDIA

    L0000918-R1024

    KD/DRUGS/KTK/25/460/2001

  • 15's carton

    Compare to CLARITIN-D® 24 HOUR active ingredients ƚ

    NDC 37808-787-35

    H.E.B

    Allergy Relief-D

    Loratadine and Pseudoephedrine Sulfate

    Exrended-Release Tablets 10 mg/ 240 mg

    Indoor & Outdoor Allergies

    24

    Hour

    Non-Drowsy*

    Antihistamine/Nasal Decongestant

    Original Prescription Strength

    15 days of Relief

    Relief of:

    • Nasal and Sinus Congestion Due to Colds or Allergies

    • Sneexing • Runny Nose • Itchy, Watery Eyes

    • Itchy Throat or Nose Due to Allergies

    15 EXTENDED- RELEASE TABLETS

    30's carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF-D 
    loratadine and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-787
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code LPS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-787-072 in 1 CARTON05/27/2025
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:37808-787-353 in 1 CARTON05/27/2025
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21801705/27/2025
    Labeler - HEB (007924756)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECIPHARM PHARMASERVICES PRIVATE LIMITED871401927manufacture(37808-787)