Label: 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 November 15, 2011

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  • Active ingredient(in each tablet)

    Chlorpheniramine Maleate 4 mg

    Purpose

    Antihistamine
  • Uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy nose or throat
    • itchy watery eyes
    • sneezing
  • Warnings


  • Ask a doctor before use if you have,

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to 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.
  • Directions


    adults and children 12 years of age and older           
    		one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours
    children 6 to under 12 years of age
    		1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
    children under 6 years of age
    		consult a physician

  • Other information

    • Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing
    • store at controlled room temperature 15o-25oC (59o-77oF)
    • protect from excessive moisture
  • Inactive ingredients: corn starch, croscarmellose sodium, D&C yellow # 10 aluminum lake 14-18%, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide


  • Questions:

    To Report Adverse Drug Events Call 800-687-0176.
  • PRINCIPAL DISPLAY PANEL

    image of label
  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-034
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code PH012
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66424-034-01100 in 1 BOTTLE, PLASTIC
    2NDC:66424-034-101000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/19/2010
    Labeler - SDA Laboratories, Inc. (948067889)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture
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