Label: ALLERGY TIME- chlorpheniramine maleate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 9, 2013

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

  • PURPOSE

    Purpose: Antihistamine>

  • INDICATIONS & USAGE

    Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:

    runny nose, sneezing, itching of the nose or throat, itch, watery eyes

  • WARNINGS

    Warnings

    Ask a doctor before use if you have:

    glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    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 operating machinery


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    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 - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

    Children under 6 years of age - do not use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.

  • PRINCIPAL DISPLAY PANEL

    This Product was Repackaged By:

    State of Florida DOH Central Pharmacy
    104-2 Hamilton Park Drive
    Tallahassee, FL 32304
    United States

    100 CT LABEL

  • INGREDIENTS AND APPEARANCE
    ALLERGY TIME 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0880(NDC:49483-242)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code TCL242
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-0880-260 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2013
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0880)
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