Label: ALLERGY RELIEF 4 HOUR- chlorpheniramine maleate tablet

  • NDC Code(s): 70000-0160-1, 70000-0160-2
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 20, 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:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use

    to make a child sleepy.

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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
    • excitability may occur, especially in children
    • 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

    • 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?

    1-800-426-9391

  • Principal display panel

    LEADER™

    NDC 70000-0160-1

    4 Hour
    Allergy Relief 

    Chlorpheniramine Maleate, 4 mg ι Antihistamine 

    Relief of:
    Sneezing, Runny Nose,
    Itchy Throat,
    Itchy, Watery Eyes

    24 TABLETS

    Actual Size

    100% Money Back Guarantee

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

    CIN 5294285 REV. 4/20 

    50844   REV0419A19408

    CardinalHealth™
    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com    1-800-200-6313
    Essential to Care™ since 1979

    ©2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO,
    ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

    All LEADER™ Brand
    Products Have A 
    100% 
    Money Back 
    Guarantee

    Return to place of purchase if not satisfied. 

    Leader 44-194

    Leader 44-194

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  4 HOUR
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0160
    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:70000-0160-12 in 1 CARTON12/19/1992
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0160-21 in 1 CARTON12/19/1992
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/19/1992
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70000-0160) , pack(70000-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(70000-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70000-0160)
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