Label: CHLORPHENIRAMINE MALEATE tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 30, 2012

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

  • Chlorpheniramine maleate 12 mg

    Antihistamine

  • USES

    temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    sneezing
    runny nose
    itchy, watery eyes
    itching of the nose or throat

  • WARNINGS

    Ask a doctor before use if you have
    a breathing problem such as emphysema or chronic bronchitis
    glaucoma
    trouble urinating due to an enlarged prostate gland
    Ask a doctor or pharmacist before use if you are
    taking sedatives or tranquilizers
    When using this product
    excitability may occur, especially in children
    drowsiness may occur
    avoid alcoholic beverages
    alchohol, sedatives and tranquilizers may increase drowsiness
    use caution when driving a motor vehicle or operating machinery
    Call your doctor for medical advice about side effects.
    You may report side effects to FDA at 1-800-FDA-1088
    If pregnant or breast-feeding, 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 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    children under 12 years of age: ask a doctor

  • OTHER INFORMATION

    each tablet contains: calcium 28 mg
    store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)
    protect from excessive moisture

  • INACTIVE INGREDIENTS

    calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

  • PURPOSE

    Chlorpheniramine maleate 12 mg is used as an antihistamine.

    Manufactured by:
    KVK-Tech, Inc.
    Newtown, PA 18940
    f2f01039-figure-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 37205-117-62
    Allergy Tablets

    Chlorpheniramine maleate 12 mg

    f2f01039-figure-02

  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 
    chlorpheniramine maleate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE12 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code Allergy;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-117-6224 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04082912/20/2010
    Labeler - Cardinal Health, Inc. (097537435)
    Registrant - KVK-Tech, Inc. (173360061)
    Establishment
    NameAddressID/FEIBusiness Operations
    KVK-Tech, Inc.173360061MANUFACTURE(37205-117)