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

  • NDC Code(s): 62011-0071-2
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 22, 2024

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  • 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. (for blister cartons only)
    • 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

    Keep the carton. It contains important information.

    See end panel for expiration date.

    Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    www.healthmart.com/healthmartbrand

  • PRINCIPAL DISPLAY PANEL - 10 mg/240 mg Tablet Blister Pack Carton

    NDC 62011-0071-2

    Health Mart ®

    Compare to Claritin-D ®24 Hour
    active ingredients †

    ORIGINAL PRESCRIPTION STRENGTH • NON-DROWSY*

    Allergy Relief &
    Nasal Decongestant

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

    Indoor & Outdoor Allergies

    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

    ACTUAL SIZE

    15 Extended-Release Tablets

    *When Taken as Directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 10 mg/240 mg 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:62011-0071
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    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
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0071-215 in 1 BLISTER PACK; Type 0: Not a Combination Product06/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655706/06/2017
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(62011-0071)
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