Label: CHLORPHENIRAMINE MALEATE - chlorpheniramine maleate tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/12

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  • Chlorpheniramine maleate 12 mg

    Antihistamine

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  • 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

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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

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  • 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

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  • 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

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  • PURPOSE

    Chlorpheniramine maleate 12 mg is used as an antihistamine.

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

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 37205-117-62
    Allergy Tablets

    Chlorpheniramine maleate 12 mg

    f2f01039-figure-02

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  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 
    chlorpheniramine maleate tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-117
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 12 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM SULFATE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    SUCROSE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 2  
    GELATIN  
    HYDROXYPROPYL CELLULOSE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    POVIDONE  
    PROPYLENE GLYCOL  
    SODIUM BENZOATE  
    SODIUM LAURETH SULFATE  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    FD&C YELLOW NO. 6  
    TALC  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code Allergy;12
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-117-62 24 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040829 12/20/2010
    Labeler - Cardinal Health, Inc. (097537435)
    Registrant - KVK-Tech, Inc. (173360061)
    Establishment
    Name Address ID/FEI Business Operations
    KVK-Tech, Inc. 173360061 MANUFACTURE(37205-117)
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