Label: ANTI ALLERGY- chlorpheniramine maleate tablet

  • NDC Code(s): 17714-016-01, 17714-016-10
  • Packager: Advance Pharmaceutical Inc.
  • 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 October 30, 2017

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  • Active Ingredient

    (in each tablet)

    Chlorpheniramine Maleate 4 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies :

    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes
  • Warnings

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating a machine
    • 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[/S]

    Adults & children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
    children 6 years to under 12 yearstake ½ tablet every 4 to 6 hours not more than 3 tablets in 24 hours
    children under 6 yearsdo not use
  • Other Information

    • each tablet contains: calcium 40 mg
    • store between 15°-30°C (59°-86°F)
    • protect from moisture
  • Inactive Ingredients

    croscarmellose sodium, D&C yellow #10 (al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

  • Questions or Comments

    Call 1-800-645-2158, 8.30 am – 4.30 pm ET, Monday - Friday

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    93a742c3-figure-01

    93a742c3-figure-02

    Chlorpheniramine Maleate 4 mg
    Antihistamine

    17714-016-01  100 Tablets

  • INGREDIENTS AND APPEARANCE
    ANTI ALLERGY 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-016
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Coloryellow (light yellow) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code AP;016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-016-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/09/2002
    2NDC:17714-016-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/09/2002
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-016)
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