Label: ALL DAY ALLERGY- cetirizine hcl capsule

  • NDC Code(s): 63868-139-25
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 2, 2021

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  • Active ingredient (in each capsule)

    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 a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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.

    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

    adults and children 6 years and overone 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
    adults 65 years and overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • store at 20º-25°C (68º-77°F)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • protect from light
  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

  • Questions or comments?

    1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in ZYRTEC®

    All Day Allergy Relief

    Indoor & Outdoor Allergies

    Cetirizine HCl Capsules, 10 mg

    Antihistamine

    24 Hour Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    SOFTGELS**

    (**Liquid-filled capsules)

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Cetirizine HCl 10 mg

    Quality Choice All Day Allergy Relief Capsule

  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-139
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code CET
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-139-251 in 1 PACKAGE04/30/201605/31/2024
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242904/30/201605/31/2024
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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