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Pill Identifier Information of cetirizine hydrochloride 10 MG Oral Tablet

Drug Information

cetirizine hydrochloride 10 MG Oral Tablet

Imprint: SZ;906
Shape: C48348
Color: C48325
Ingredients: Cetirizine
Size: 8.00
Score: 1
Rxtty: SCD
Author: Physicians Total Care, Inc.
Inactive Ingredients: STARCH, CORN / HYPROMELLOSES / LACTOSE MONOHYDRATE / MAGNESIUM STEARATE / POVIDONE / TITANIUM DIOXIDE / POLYETHYLENE GLYCOL>

Complete Information

  • Active ingredient

    (in each tablet)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 reactions 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
    •
    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.

    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 over

    One 10 mg tablet once daily; do not take more than one 10 mg tablet 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 between 20º to 25º C (68º to 77º F)
  • Inactive ingredients

    Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

    Questions? 1-800-525-8747

    Manufactured in India by Sandoz Private Ltd.,

    for Sandoz Inc., Princeton, NJ 08540

    Rev.06/2013

    Distributed by: 

    Physicians Total Care, Inc.

    Tulsa, OK  74146

  • Principal Display Panel

    NDC 0781-1684-64

    Cetirizine HCl Tablets, USP

    10 mg

    antihistamine

    30 Tablets.

    Do not use if individual blister unit is open or torn

    ALLERGY

    Indoor & Outdoor Allergies

    24 hour Relief of

    •
    Sneezing
    •
    Runny Nose
    •
    Itchy, Watery Eyes
    •
    Itchy Throat or Nose
    Certrizine 10mg
  • PRINCIPAL DISPLAY PANEL

    Certrizine 10mg back base

    NDC 54868-5845-0

    Cetirizine HCl Tablets, USP

    10 mg

    antihistamine

    package label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5845(NDC:0781-1684)
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONES (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeROUND (round shape) Size8mm
    FlavorImprint Code SZ;906
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5845-0100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:54868-5845-114 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:54868-5845-230 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:54868-5845-390 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07794601/02/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-5845)