WAL-ITIN D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]

  • Home
  • WAL-ITIN D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]

WAL-ITIN D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]
PDF | XML
NDC 0363-2390-12, 0363-2390-72, 0363-2390-79
Set ID f0d6da14-8386-4d84-9f21-ce6708edddc3
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA075706
View All Sections
  • Drug Facts

  • Active ingredients (in each tablet)

    Loratadine, USP 10 mg
    Pseudoephedrine sulfate, USP 240 mg

  • Purposes

    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

    ● temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • 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.

  • 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

    • safety sealed: do not use if blister unit is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from light and store in a dry place
  • Inactive ingredients

    black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc and titanium dioxide

  • QUESTIONS

    Questions? 1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    Compare to Claritin-D® 24 Hour active ingredients††

    NDC 0363-2390-72

    NON-DROWSY*

    Wal-itin® D

    LORATADINE, USP 10 mg /

    PSEUDOEPHEDRINE SULFATE, USP 240 mg

    EXTENDED-RELEASE TABLETS

    ANTIHISTAMINE / NASAL DECONGESTANT

    24 HOUR ALLERGY & CONGESTION

    24 HOUR  EXTENDED -RELEASE TABLETS
    INDOOR & OUTDOOR ALLERGIES

    • 24-hour relief of nasal & sinus congestion due to colds or allergies
    • 24-hour relief of sneezing, runny nose, itchy, watery eyes &
      itchy throat or nose due to allergies

    24 HOUR

    5 EXTENDED-RELEASE TABLETS

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    image
    image
  • INGREDIENTS AND APPEARANCE
    WAL-ITIN D  24 HOUR
    loratadine and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2390
    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)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code Andrx;605
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2390-721 in 1 CARTON03/01/2016
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-2390-792 in 1 CARTON03/01/2016
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-2390-123 in 1 CARTON03/01/2016
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570603/01/2016
    Labeler - Walgreen Company (008965063)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
View All Sections

Related Drugs

Search DailyMed Drugs