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

  • NDC Code(s): 49348-543-01, 49348-543-57
  • Packager: STRATEGIC SOURCING SERVICES
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 30, 2020

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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.sunmarkbrand.com

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

    sunmark®

    COMPARE TO CLARITIN-D® 24 HOUR
    TABLETS ACTIVE INGREDIENTS**

    NDC 49348-543-57

     
    24 HOUR
    Original Prescription Strength

    allergy & congestion

    lorata•dine D

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

    Extended-Release Tablets

    Indoor & Outdoor Allergies

    Relief of Nasal and Sinus Congestion
    Due to Colds or Allergies
    Sneezing; Runny Nose; Itchy, Watery Eyes;
    Itchy Throat or Nose Due to Allergies

    NON-DROWSY*

    15 Extended-Release Tablets

    *When taken
    as directed.
    See Drug
    Facts Panel.

    PRINCIPAL DISPLAY PANEL - 240 mg/10 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:49348-543
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    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
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-543-0110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
    2NDC:49348-543-5715 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 - STRATEGIC SOURCING SERVICES (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(49348-543)
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