Label: CHLORTAB- chlorpheniramine maleate tablet 

  • Label RSS
  • NDC Code(s): 55312-463-78
  • Packager: Western Family Foods Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 10/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

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  • Purpose

    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

    Do not use

    to make a child sleepy

    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
    alcohol, sedatives and tranquilizers may increase drowsiness
    use caution when driving a motor vehicle or operating machinery

    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. (1-800-222-1222)

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  • Directions

    adults and children 12 years and over

    1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

    children 6 to under 12 years of age

    ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

    children 4 to under 6 years of age

    do not use unless directed by a doctor

    children under 4 years of age

    do not use

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  • Other information

    Store between 20º to 25ºC (60º to 70ºF)

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  • Inactive ingredients

    D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

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  • Principal Display Panel

    4 HOUR ALLERGY RELIEF

    COMPARE TO CHLOR-TRIMETON® active ingredient

    ChlorTab

    Allergy-4 Hour

    Gluten Free

    CHLORPHENIRAMINE MALEATE – ANTIHISTAMINE

    Actual Size

    ChlorTab Carton Image 1
    ChlorTab Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    CHLORTAB 
    chlorpheniramine maleate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55312-463
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code L463
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-463-78 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/22/2007
    Labeler - Western Family Foods Inc (192166072)
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