Label: ALLERGY RELIEF D- cetirizine hcl, pseudoephedrine hcl tablet, extended release

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

Drug Label Information

Updated December 4, 2019

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

View All Sections
  • Active ingredients (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

  • Principal Display Panel

    Compare to Zyrtec-D® active ingredients

    Allergy Relief-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

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat or Nose

    Sinus Pressure

    Nasal Congestion

    12 Hour

    actual size

    12 EXTENDED RELEASE TABLETS

    Allergy Relief-D Carton Image 1
    Allergy Relief-D Carton Image 2
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF D 
    cetirizine hcl, pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-785
    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)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    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:37808-785-5312 in 1 CARTON01/19/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:37808-785-6224 in 1 CARTON01/19/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07717001/19/2018
    Labeler - H E B (007924756)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!