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 April 19, 2022

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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, watery eyes
    • sneezing
    • itching of the nose or throat
  • 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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 (1-800-222-1222).

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    adults and children 12 years and over  1 tablet. Do not exceed 6 tablets in 24 hours.
    children 6 to under 12 years  1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
    children under 6 years do not use


  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from excessive moisture
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

  • Questions or comments?

    1-800-645-2158

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    They are supplied as follows:

    NDC 55289-560-24 bottles of 24

    NDC 55289-560-30 bottles of 30

    NDC 55289-560-01 bottles of 100

  • Principal Display Panel

    Chlorpheniramine Maleate
    4 mg

    55289560 Label
  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-560(NDC:0536-1006)
    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)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55289-560-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2021
    2NDC:55289-560-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2021
    3NDC:55289-560-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/19/1992
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(55289-560)