Label: ALL DAY ALLERGY D- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/14

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

  • Active ingredient (in each extended release tablet)

    Cetirizine HCl 5 mg

    Pseudoephedrine HCl 120 mg

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  • Purpose

    Antihistamine

    Nasal Decongestant

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  • 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
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  • 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.

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  • 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

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  • Other information

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

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

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  • Questions or comments?

    1-800-632-6900

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  • Principal Display Panel

    COMPARE TO the active ingredients of ZYRTEC-D®

    See side panel

    ORIGINAL PRESCRIPTION STRENGTH

    All Day Allergy-D

    Cetirizine Hydrochloride and Pseudoephedrine

    Hydrochloride Extended Release Tablets, 5 mg/120 mg

    Antihistamine/Nasal Decongestant

    ALLERGY & CONGESTION

    Indoor & Outdoor Allergies

    12 Hour Relief of:

    Sneezing

    Runny Nose

    Sinus Pressure

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Nasal Congestion

    12 HOUR

    24 EXTENDED RELEASE TABLETS

    actual size

    All Day Allergy-D Image 1
    All Day Allergy-D Image 2
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  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY D 
    cetirizine hcl, pseudoephedrine hcl tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-176
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    TALC  
    FERRIC OXIDE YELLOW  
    Product Characteristics
    Color WHITE (one side white one side light yellow) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code 5029;5;120
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-176-62 12 in 1 CARTON
    1 2 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077170 02/19/2014
    Labeler - Kroger Company (006999528)
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