Label: ALLERGY- chlorpheniramine maleate tablet

  • NDC Code(s): 0904-0012-24, 0904-0012-59, 0904-0012-61, 0904-0012-80
  • Packager: Major Pharmaceuticals
  • 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 January 4, 2023

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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  
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    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) right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    adults and children 12 years and over1 tablet. Do not exceed 6 tablets in 24 hours.
    children 6 to under 12 years1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
    children under 6 yearsdo not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from excessive moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-0012-24

    4 Hour

    Allergy Tablets
    Chlorpheniramine Maleate
    4 mg
    Antihistamine

    Relieves
    Sneezing, Runny Nose,
    Itchy, Watery Eyes,
    Itchy Throat

    Actual Size

    24 Tablets

    TAMPER EVIDENT: DO NOT USE IF
    PACKAGE IS OPENED OR
    IF BLISTER UNIT IS TORN,
    BROKEN OR SHOWS ANY SIGNS
    OF TAMPERING

    50844              REV0419ML19408

    Distributed by:
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

    Rev. 10/19         M-17       Re-order No. 700790

    Major 44-194

    Major 44-194


  • Principal Display Panel - Unit Dose

    NDC 0904-0012-61

    MAJOR®

    Unit Dose

    ALLERGY TABLETS
    CHLORPHENIRAMINE MALEATE

    Antihistamine

    4 mg
    100 TABLETS

    This Unit Dose package is not child resistant and
    is Intended for Institutional Use Only.

    50844     REV0419B19412

    Distributed by:
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152

    Rev. 10/19    M-17  Re-order   No. 301560

    Major 44-194-DSP

    Major 44-194-DSP

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0012
    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)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-0012-591 in 1 CARTON12/19/1992
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0904-0012-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/1992
    3NDC:0904-0012-242 in 1 CARTON12/19/1992
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0904-0012-6110 in 1 CARTON12/19/1992
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/19/1992
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0904-0012) , pack(0904-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0904-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(0904-0012)
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