SUNMARK ALL DAY ALLERGY D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]

SUNMARK ALL DAY ALLERGY D (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]
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NDC 50090-2537-1
Set ID f1ac3a42-d802-4ffb-9bc1-28529775d8fa
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA077170
  • Active ingredient (in each extended release tablet)

    Cetirizine HCl 5 mg

    Pseudoephedrine HCl 120 mg

  • Purpose

    Antihistamine

    Nasal Decongestant

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
    nasal congestion
    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 or to an antihistamine containing hydroxyzine.
    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
    diabetes
    glaucoma
    high blood pressure
    trouble urinating due to an enlarged prostate gland
    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    do not use more than directed
    drowsiness may occur
    avoid alcoholic drinks
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.
    you get nervous, dizzy, or sleepless
    symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast-feeding:

    if breast-feeding: not recommended
    if pregnant: 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 break or chew tablet; swallow tablet whole

    adults and children 12 years and over

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

    adults 65 years and over

    ask a doctor

    children under 12 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

  • Other information

    store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

  • Questions or comments?

    1-800-719-9260

  • HOW SUPPLIED

    Product: 50090-2537

    NDC: 50090-2537-1 6 TABLET, EXTENDED RELEASE in a BLISTER PACK / 4 in a CARTON

  • Cetirizine HCl, Pseudoephedrine HCl

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUNMARK ALL DAY ALLERGY D 
    cetirizine hcl, pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2537(NDC:49348-851)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorWHITE (one side white one side light yellow) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 5029;5;120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-2537-14 in 1 CARTON10/19/2016
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07717004/18/2008
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-2537)

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