Label: ALLERGY RELIEF-D 24 HOUR 24 HOUR- 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 February 1, 2018

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

  • Drug Facts
  • Active ingredients (in each tablet)

    Loratadine, USP 10 mg
    Pseudoephedrine sulfate, USP 240 mg

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  • Purposes

    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

    • 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
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  • 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

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  • Questions?

    1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

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  • Principal Display Panel

    Actavis

    NDC 52544-239-12
    Compare to the active ingredients 
    in Claritin-D® 24 Hour

    Non-Drowsy*
    Allergy Relief-D
    Loratadine, USP 10 mg/Pseudoephedrine Sulfate, USP 240 mg
    Extended-Release Tablets
    Antihistamine/Nasal Decongestant

    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

    *When taken as directed. See Drug Facts Panel.

    Indoor & Outdoor Allergies
    Allergy & Congestion
    15 Extended-Release Tablets

    image

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF-D 24 HOUR  24 HOUR
    loratadine and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52544-239
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code Andrx;605
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52544-239-12 3 in 1 CARTON 06/14/2018
    1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075706 06/14/2018
    Labeler - Actavis Pharma, Inc. (119723554)
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