Label: 4 HOUR ALLERGY RELIEF- chlorpheniramine maleate tablet

  • NDC Code(s): 21130-009-08
  • Packager: Better Living Brands, LLC
  • 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 September 18, 2019

If you are a consumer or patient please visit this version.

  • 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

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

    adults and children 12
    years of age and over
    1 tablet every 4 to 6 hours. Do
    not take more than 6 tablets in
    24 hours.
    children 6 to under 12
    years of age
    1/2 tablet (break tablet in half)
    every 4 to 6 hours. Do not
    exceed 3 whole tablets in 24
    hours.

    children under 6 years
    of age

    do not use this product in
    children under 6 years of age

  • 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

    Signature
    care

    Quality Guaranteed

    NDC 21130-009-08

    4 HOUR
    Allergy Relief

    Chlorpheniramine Maleate 4 mg
    Antihistamine

    Actual Size

    24 TABLETS

    Compare to
    Chlor-Trimeton®
    Allergy Tablets
    active ingredient*

    • Relief of:
    Sneezing, runny nose,
    itchy throat,
    itchy & watery eyes

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

    *This product is not manufactured or
    distributed by MSD Consumer Care, Inc.,
    distributors of Chlor-Trimeton® Allergy
    Tablets.
    50844        ORG021319408

    DISTRIBUTED BY BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100%
    GUARANTEED

    OR YOUR MONEY BACK.

    Signature Care 44-194

    Signature Care 44-194

  • INGREDIENTS AND APPEARANCE
    4 HOUR ALLERGY RELIEF 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-009
    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 (UNII: 35SW5USQ3G)  
    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:21130-009-082 in 1 CARTON12/19/199207/22/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/19/199207/22/2022
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(21130-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(21130-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(21130-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(21130-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(21130-009)