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Pill Identifier Information of cetirizine hydrochloride 10 MG Oral Tablet

Drug Information

cetirizine hydrochloride 10 MG Oral Tablet

Imprint: M;C37
Shape: C48348
Color: C48325
Ingredients: Cetirizine
Size: 8.00
Score: 1
Rxtty: SCD
Author: Mylan Pharmaceuticals Inc.
Inactive Ingredients: ANHYDROUS LACTOSE / SILICON DIOXIDE / HYPROMELLOSE / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYDEXTROSE / POLYETHYLENE GLYCOL / SODIUM LAURYL SULFATE / TITANIUM DIOXIDE / TRIACETIN>

Complete Information

  • Active Ingredient (in each tablet)

    Cetirizine hydrochloride USP, 5 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
    •
    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

    1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.

    adults 65 years and over

    1 tablet once a day; do not take more than 1 tablet in 24 hours

    children under 6 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

    Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

  • Questions?

    Call 1-877-446-3679 (1-877-4-INFO-RX)

    Manufactured for:
    Mylan Pharmaceuticals Inc.

    Morgantown, WV 26505

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 5 mg Allergy

    NDC 0378-3635-01

    Cetirizine HCl
    Tablets, USP
    Allergy
    5 mg
    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of

    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat

    RMX-AR3635A     100 Tablets

    Tamper Evident: do not use if foil seal
    under cap is missing, open or broken.

    Cetirizine Hydrochloride Tablets 5 mg - Front Layer - Bottle Label
    Cetirizine Hydrochloride Tablets 5 mg - Back of Front Layer - Bottle Label
    Cetirizine Hydrochloride Tablets 5 mg - Base Layer - Bottle Label
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 10 mg Allergy

    NDC 0378-3637-01

    Cetirizine HCl
    Tablets, USP
    Allergy
    10 mg
    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of

    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat

    RMX-AR3637A     100 Tablets     

    Tamper Evident: do not use if foil seal
    under cap is missing, open or broken.

    Active Ingredient (in each tablet)
    Cetirizine hydrochloride USP, 10 mg

    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

    Cetirizine Hydrochloride Tablets 10 mg - Front Layer - Bottle Label
    Cetirizine Hydrochloride Tablets 10 mg - Back of Front Layer - Bottle Label
    Cetirizine Hydrochloride Tablets 10 mg - Base Layer - Bottle Label
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-3635
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code M;C35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0378-3635-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07667712/27/2007
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-3637
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code M;C37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0378-3637-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2007
    2NDC:0378-3637-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07667712/27/2007
    Labeler - Mylan Pharmaceuticals Inc. (059295980)