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

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

Drug Label Information

Updated April 28, 2020

If you are a consumer or patient please visit this version.

  • 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 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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
    • 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.

  • SPL UNCLASSIFIED SECTION

    Distributed By

    MAJOR ® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Loratadine and Pseudoephedrine Sulfate

    GENERIC: Loratadine and Pseudoephedrine Sulfate

    DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

    ADMINSTRATION: ORAL

    NDC: 70518-0371-0

    NDC: 70518-0371-1

    COLOR: white

    SHAPE: CAPSULE

    SCORE: No score

    SIZE: 17 mm

    IMPRINT: RX724

    PACKAGING: 15 in 1 BLISTER PACK

    PACKAGING: 5 in 1 BOTTLE PLASTIC

    ACTIVE INGREDIENT(S):

    • PSEUDOEPHEDRINE SULFATE 240mg in 1
    • LORATADINE 10mg in 1

    INACTIVE INGREDIENT(S):

    • TITANIUM DIOXIDE
    • SODIUM CITRATE, UNSPECIFIED FORM
    • SODIUM ALGINATE
    • SHELLAC
    • PROPYLENE GLYCOL
    • STARCH, CORN
    • POVIDONE, UNSPECIFIED
    • TALC
    • POLYETHYLENE GLYCOL, UNSPECIFIED
    • MAGNESIUM STEARATE
    • LACTOSE MONOHYDRATE
    • FERROSOFERRIC OXIDE
    • HYPROMELLOSE, UNSPECIFIED
    • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
    • SILICON DIOXIDE
    • MICROCRYSTALLINE CELLULOSE
    • CALCIUM CARBONATE

    Remedy_Label

    MM2

  • 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:70518-0371(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
    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)  
    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:70518-0371-015 in 1 BLISTER PACK; Type 0: Not a Combination Product03/29/2017
    2NDC:70518-0371-15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655703/29/2017
    Labeler - REMEDYREPACK INC. (829572556)