Label: ALLER-CHLOR- chlorpheniramine maleate tablet

  • NDC Code(s): 0536-1006-01, 0536-1006-10, 0536-1006-35
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 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
    • 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) right away.

  • 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
    • 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?

    1-800-645-2158

  • Principal Display Panel

    Rugby®

    NDC 0536-1006-01

    4 Hour

    Aller-chlor®

    Chlorpheniramine Maleate
    4 mg
    Antihistamine

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

    Actual Size

    100 Tablets

    50844     REV0419A19412

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152
    www.rugbylaboratories.com

    Rev. 10/19    R-17    Re-order No. 370295

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Rugby 44-194

    Rugby 44-194

  • INGREDIENTS AND APPEARANCE
    ALLER-CHLOR 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    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:0536-1006-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/1992
    2NDC:0536-1006-011 in 1 CARTON12/19/1992
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0536-1006-352 in 1 CARTON02/15/201910/31/2020
    312 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 - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0536-1006)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0536-1006) , pack(0536-1006)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0536-1006)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0536-1006)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(0536-1006)
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