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

Drug Label Information

Updated April 9, 2024

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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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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?

    1-800-426-9391

  • Principal Display Panel

    NDC 0904-0012-24

    MAJOR®

    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   REV0419N19408

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    Questions or comments? (800) 616-2471
    www.majorpharmaceuticals.com

    Rev. 06/23    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 each

    Institutional Dispensing Only
    100 TABLETS

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

    50844     REV0419C19412

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    (800) 616-2471
    www.majorpharmaceuticals.com

    Rev. 03/23    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:0904-0012-242 in 1 CARTON12/19/1992
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-0012-591 in 1 CARTON12/19/1992
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0904-0012-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/1992
    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 DrugM01212/19/1992
    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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