LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]

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LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]
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NDC 70518-0653-0
Set ID af51f2ae-6f90-4cac-96e9-5faed3b07847
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA076557
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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 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 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 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

  • PRINCIPAL DISPLAY PANEL

    DRUG: Loratadine and Pseudoephedrine

    GENERIC: loratadine and pseudoephedrine

    DOSAGE: TABLET, EXTENDED RELEASE

    ADMINSTRATION: ORAL

    NDC: 70518-0653-0

    NDC: 70518-0653-1

    COLOR: white

    SHAPE: CAPSULE

    SCORE: No score

    SIZE: 17 mm

    IMPRINT: RX724

    PACKAGING: 5 in 1 BOTTLE, PLASTIC

    PACKAGING: 1 in 1 CARTON, 15 in 1 BLISTER PACK TYPE 0

    ACTIVE INGREDIENT(S):

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

    INACTIVE INGREDIENT(S):

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

    MM1

    MM2

  • INGREDIENTS AND APPEARANCE
    LORATADINE AND PSEUDOEPHEDRINE 
    loratadine and pseudoephedrine tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0653(NDC:51660-724)
    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)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RX724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-0653-05 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2017
    2NDC:70518-0653-11 in 1 CARTON09/10/2021
    215 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07655707/31/2017
    Labeler - REMEDYREPACK INC. (829572556)
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