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

  • NDC Code(s): 68016-724-15, 68016-724-69
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Loratadine, USP 10 mgAntihistamine
    Pseudoephedrine sulfate, USP 240 mgNasal 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 condtions, 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 over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask 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

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

  • PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

    COMPARE TO THE ACTIVE
    INGREDIENTS OF CLARITIN-D® 24 HOUR†

    Original Prescription Strength
    NON-DROWSY*

    Premier
    Value®

    24 Hour Allergy Relief

    Loratadine, USP 10 mg/Antihistamine
    Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

    ALLERGY RELIEF and
    NASAL DECONGESTANT

    Indoor & Outdoor Allergies

    Relief of:

    ✓
    Nasal & Sinus Congestion Due to Colds or Allergies
    ✓
    Sneezing; Runny Nose; Itchy, Watery Eyes;
    Itchy Throat or Nose Due to Allergies

    10
    Allergy & Congestion
    Extended-Release Tablets

    INDEPENDENTLY TESTED
    SATISFACTION GUARANTEED

    *When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
  • 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:68016-724
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-724-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
    2NDC:68016-724-1515 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 - Chain Drug Consortium, LLC (101668460)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(68016-724)
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