Label: ALLERGY RELIEF-D 24 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release

  • NDC Code(s): 37012-239-79
  • Packager: Shopko Stores Operating Co., LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 1, 2021

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  • Drug Facts

  • Active ingredients (in each tablet)

    Loratadine, USP 10 mg
    Pseudoephedrine sulfate, USP 240 mg

  • Purposes

    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.

  • 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 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, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc and titanium dioxide

  • QUESTIONS

    Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • PRINCIPAL DISPLAY PANEL

    PDP

    Shopko®
    NDC 37012-239-79
    **Compare to Claritin-D® 24 Hour active ingredients
    Non-Drowsy*
    Allergy Relief-D
    Loratadine, USP 10mg/Pseudoephedrine Sulfate, USP 240 mg
    Extended- Release Tablets
    Antihistamine / Nasal Decongestant
    Indoor & Outdoor Allergies

    Allergy & Congestion
    24 Hour 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.
    10 Extended-Release Tablets

    Allergy Relief D

     

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF-D  24 HOUR
    loratadine and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-239
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code Andrx;605
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-239-792 in 1 CARTON03/01/2016
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570603/01/201605/31/2024
    Labeler - Shopko Stores Operating Co., LLC. (023252638)
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