Home > Pill Identifier > loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Tablet

Pill Identifier Information of loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Tablet

Drug Information

loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Tablet

Imprint: RX724
Shape: C48336
Color: C48325
Ingredients: Loratadine; Pseudoephedrine
Size: 17.00
Score: 1
Rxtty: SY
Author: Major Pharmaceuticals
Inactive Ingredients: CALCIUM CARBONATE / COLLOIDAL SILICON DIOXIDE / HYDROXYPROPYL CELLULOSE / HYPROMELLOSES / FERROSOFERRIC OXIDE / LACTOSE MONOHYDRATE / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOLS / POVIDONE / STARCH, PREGELATINIZED CORN / PROPYLENE GLYCOL / SHELLAC / SODIUM ALGINATE / SODIUM CITRATE / TALC / TITANIUM DIOXIDE>

Complete Information

  • 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

    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

    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

  • 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.

  • SPL UNCLASSIFIED SECTION

    Distributed By
    MAJOR ®PHARMACEUTICALS
    Indianapolis, IN 46268

    (800) 616-2471

    www.major-rugby.com

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

    MAJOR ®

    NDC 0904-5833-15

    compare to the active ingredients in
    Claritin-D ®24 Hour**

    non-drowsy*

    loratadine-D

    original prescription strength

    pseudoephedrine sulfate, USP 240 mg

    nasal decongestant
    loratadine, USP 10 mg

    antihistamine

    24 hour

    indoor & outdoor allergies

    allergy & congestion

    relief of:

    nasal and 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.

    10 extended-release tablets

    lorad

  • 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:0904-5833
    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
    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)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5833-1510 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
    2NDC:0904-5833-4815 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 - Major Pharmaceuticals (191427277)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(0904-5833)