Label: ALLERGY RELIEF- cetirizine hcl 10 mg capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient (in each softgel)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • 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
  • 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

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when drivinga motor vehicle or operating machinery

    Stop use and ask doctor

    if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms
    • Adults 65 years and over: ask a doctor
    • Children under 6 years of age: ask a doctor
    • Consumers with liver or kidney disease: ask a doctor
  • Other information

    • store between 20°C to 25°C (68°F to 77°F )
    • do not use if imprinted safety seal under cap is broken or missing 
  • Inactive Ingredients

    butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink

  • Questions or Comments?

    Call 1-888-952-0050

    Monday through Friday 9AM – 5PM EST

    Manufactured for

    A&Z Pharmaceutical, Inc.
    Hauppauge, NY 11788

  • Package/Label Principal Display Panel

    Cetirizine HCl 10mg Softgels

    Cetirizine HCl 10mg Softgels

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl 10 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-392
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-392-251 in 1 CARTON12/16/2014
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831712/16/2014
    Labeler - Allegiant Health (079501930)
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

More Info on this Drug

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