Label: CHLORPHENIRAMINE MALEATE 4MG tablet, coated

  • 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 November 14, 2017

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

  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4mg

  • 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

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • 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

    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
    • Children 6 to under 12 years of age: ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
    • Children under 6 years of age: ask a doctor
  • Other information

    • store between 20°-25°C (68°-77°F)
    • do not use if seal under cap is broken or missing
  • Inactive ingredients

    D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions or Comments?

    1-888-952-0050 (Monday-Friday 9AM-5PM EST)

  • Principal Display Panel

    Clear Choice (logo)

    ALLERGY RELIEF

    Antihistamine 

    Chlorpheniramine Maleate

    4Hour

    RELIEVES: SNEEZING, WATERY EYES, ITCHY THROAT, RUNNY NOSE

    Compare to Chlor-Trimenton®*

    24 Tablets

    4mg Each

    Allergy Relief 4 Hour 24ct. Tablets

    Allergy Relief 4 Hour 24ct. Tablets

  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 4MG 
    chlorpheniramine maleate 4mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-277
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AZ;246
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53185-277-2424 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/15/2014
    Labeler - Athlete's Needs, Inc. (619703945)