Label: ALLERGY RELIEF- cetirizine hcl capsule

  • NDC Code(s): 69230-303-24, 69230-303-40
  • Packager: Camber Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 7, 2023

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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
  • Warning

  • 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 (1-800-222-1222) 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 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 at 20ºto 25oC (68o to 77o F)
    • avoid high humidity and excessive heat above 40o C (104o F)
    • protect from light
  • Inactive Ingredients

    Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

  • Questions or comments?

    Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in ZYRTEC® Liquid Gels

    Allergy Relief

    Cetirizine HCI Capsules,10 mg/Antihistamine

    24 Hour Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat or nose

    Indoor and outdoor allergies

    Original Prescription Strength

    Softgels

    (**Liquid-Filled Capsules)

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec® Liquid Gels

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    Camber Consumer Care Inc, Piscataway, NJ 08854, USA

  • Product Label

    Cetirizine HCI 10 mg

    CAMBER CONSUMER CARE Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-303
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-303-241 in 1 BOX12/31/201812/31/2024
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69230-303-401 in 1 BOX12/31/201812/31/2024
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20723512/31/201812/31/2024
    Labeler - Camber Consumer Care (079539968)
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