Label: ALAVERT ALLERGY SINUS D-12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 0573-2660-12, 0573-2660-24
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 24, 2020

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

  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Loratadine 5 mg

    Pseudoephedrine sulfate 120 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 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
    store between 20° and 25°C (68° and 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?

    Call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2660-24

    Compare ours to the Active Ingredients in
    Claritin-D® 12 Hour Tablets

    allergy & congestion

    ALAVERT®
    D-12
    HOUR

    Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
    Loratadine 5 mg/Antihistamine — Extended Release Tablets

    Non-Drowsy*
    Relief of:
    • Nasal and Sinus Congestion Due to Colds or Allergies
    • Sneezing • Runny Nose • Itchy, Watery Eyes
    • Itchy Throat or Nose Due to Allergies

    Indoor & Outdoor Allergies

    This product is not manufactured by Bayer HealthCare LLC, the distributor of Claritin-D® 12 Hour Tablets.

    24 TABLETS

    Actual Size

    *When taken as directed.
    See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ALAVERT ALLERGY SINUS D-12 
    loratadine, pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2660
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeROUND (round shape and an extra deep convex) Size14mm
    FlavorImprint Code Alavert;D12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2660-122 in 1 CARTON01/30/2004
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2660-244 in 1 CARTON01/30/2004
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07605001/30/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)