Label: ALLERGY- chlorpheniramine maleate tablet

  • 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 December 16, 2013

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  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

  • Purpose

    Antihistamine

  • Use

    • 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

    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 right away.

  • Directions

     adults and children 12 years of age and older  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 tablets in 24 hours.
     children under 6 years of age
    		  do not use this product in children under 6 years of age

  • 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?

    (800) 616-2471

  • Principal Display Panel

    NDC 33261-0222-30

    Allergy
    Tablets
    Antihistamine

    RELIEVES: Sneezing,
    Itchy, Watery Eyes,
    Itchy Throat, Runny Nose

    *Compare to the active ingredient in Chlor-Trimeton® Allergy Tablets

    Chlorpheniramine maleate 4 mg EACH

    4 hour
    24 TABLETS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Chlor-Trimeton® Allergy Tablets.
    50844    REV0512K19408

    Distributed by Major Pharmaceuticals
    31778 Enterprise Drive
    Livonia, MI 48150 USA

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

    REV. 05/12
    M-17

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

    IMAGE LABEL

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-222(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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 44;194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33261-222-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/19/1992
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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