Label: 12 HOUR ALLERGY AND CONGESTION- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 0363-1133-46, 0363-1133-60, 0363-1133-65
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 22, 2019

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

  • Active ingredients (in each tablet)

    Loratadine 5 mg

    Pseudoephedrine sulfate 120 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
    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 (1-800-222-1222).

  • Directions

    do not divide, crush, chew or dissolve the tablet

    adults and children 12 years and over

    1 tablet every 12 hours; not more than 2 tablets in 24 hours

    children under 12 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

  • Other information

    each tablet contains: calcium 25 mg
    do not use if blister unit is broken or torn
    store between 20° to 25°C (68° to 77°F)
    keep in a dry place
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    NON-DROWSY*

    Wal-itin® D

    Compare to Claritin-D® 12 Hour Tablets active ingredients

    12 HOUR ALLERGY & CONGESTION

    PSEUDOEPHEDRINE SULFATE 120 mg / NASAL DECONGESTANT

    LORATADINE 5 mg / ANTIHISTAMINE

    EXTENDED-RELEASE TABLETS

    12 HOUR - EXTENDED RELEASE TABLETS

    INDOOR & OUTDOOR ALLERGIES

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

    30 EXTENDED-RELEASE TABLETS

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    12 HOUR

    ACTUAL SIZE

    walitin d image
  • INGREDIENTS AND APPEARANCE
    12 HOUR ALLERGY AND CONGESTION 
    loratadine, pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (to off-white) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 7U0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1133-4610 in 1 CARTON05/05/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-1133-6020 in 1 CARTON05/05/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-1133-6530 in 1 CARTON05/05/2018
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07605005/05/2018
    Labeler - Walgreen Company (008965063)