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 August 25, 2010

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  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Chlorpheniramine maleate 4 mg

  • PURPOSE

    Antihistamine

  • USES

    • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes
  • WARNINGS

    Do not use

    to make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • alcohol, sedatives and tranquilizers may increase drowsiness
    • drowsiness may occur
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • be careful 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

    take every 4 to 6 hours, not more than 6 doses in 24 hours

    adults and children 12 years of age and over1 tablet (4 mg)
    children 6 to under 12 years of age1/2 tablet (2 mg)
    children 4 to under 6 years of age

    do not use unless

    directed by a doctor
    children under 4 years of agedo not use
  • OTHER INFORMATION

    • store at room temperature
    • protect from moisture
  • INACTIVE INGREDIENTS

    D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, starch and stearic acid.

  • QUESTIONS OR COMMENTS?

    Manufactured by:

    Contract Pharmacal Corporation

    135 Adams Ave

    Hauppauge, NY 11788, USA

    www.cpc.com

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--09/2010--NJW

  • Package Label

    Blister of 30 Tablets

    Blister of 30 Tablets

  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-093(NDC:10267-0997)
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-093-1414 in 1 BLISTER PACK
    2NDC:67046-093-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/30/2010
    Labeler - Contract Pharmacy Services-PA (945429777)
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