Label: LORATADINE AND PSEUDOEPHEDRINE tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2021

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  • Active ingredient

    Loratadine, USP 10 mg

    Pseudoephedrine sulfate, USP 240

  • 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

    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

    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
  • 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
  • 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

  • PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton

    Compare to active ingredients in
    Claratin-D® 24 hour**

    NDC 46122-383-22

    GOOD
    NEIGHBOR
    PHARMACY®

    Non-Drowsy*
    24 HOUR

    Allergy &
    Congestion Relief
    pseudoephedrine sulfate, USP 240 mg/nasal decongestant
    loratadine, USP 10 mg/antihistamine

    Indoor & Outdoor Allergies

    Extended-Release Tablets

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

    15 tablets

    *When taken as directed. See Drug Facts Panel.

    Principal Display Panel - 15 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE AND PSEUDOEPHEDRINE 
    loratadine and pseudoephedrine tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-383
    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 (1600000 WAMW) (UNII: RFW2ET671P)  
    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)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-383-2215 in 1 BLISTER PACK; Type 0: Not a Combination Product08/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655708/02/2017
    Labeler - AMERISOURCE BERGEN (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(46122-383)
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