Label: CHLORPHEN-12- chlorpheniramine maleate tablet, film coated, extended release

  • NDC Code(s): 10702-017-01, 10702-017-04, 10702-017-06, 10702-017-24, view more
    10702-017-54
  • Packager: KVK-Tech, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2018

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  • Chlorpheniramine maleate 12 mg

    Antihistamine

  • USES

    temporarily relieves the following 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
    alchohol, sedatives and tranquilizers may increase drowsiness
    use caution when driving a motor vehicle or operating machinery
    Call your doctor for medical advice about side effects.
    You may report side effects to FDA at 1-800-FDA-1088
    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 and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
      children under 12 years of age: ask a doctor

  • OTHER INFORMATION

    • each tablet contains: calcium 28 mg
      store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)
      protect from excessive moisture

  • INACTIVE INGREDIENTS

    • calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

  • PURPOSE

    Chlorpheniramine maleate 12 mg is used as an antihistamine.

    Manufactured by:

    KVK-Tech, Inc.
    Newtown, PA 18940

    logo

  • Principal Display Panel - 24 Tablets Carton

    New Look. Same Trusted Ingredient. MADE IN USA

    NDC 10702-017-24

    Chlorphen-12

    Allergy

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


    3 in 1
    Fast Acting
    Long Lasting
    Less Drowsy


    24 Tablets

    Indoor & Outdoor Allergies
    12-hour Extended-Release Tablets

    Chlorpheniramine Maleate 12 mg/Antihistamine

    24 tab pic 1

    24 tabs pic 2

  • Principal Display panel - 60 Tablets Container Label

    New Look. Same Trusted Ingredient. MADE IN USA
    NDC 10702-017-06


    Chlorphen-12
    Allergy

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

    3 in 1
    Fast Acting
    Long Lasting
    Less Drowsy


    60 Tablets

    Indoor & Outdoor Allergies
    12-hour Extended-Release Tablets
    Chlorpheniramine Maleate 12 mg/Antihistamine

    container label - 60s

  • PRINCIPAL DISPLAY PANEL

    New Look. Same Trusted Ingredient. MADE IN USA
    NDC 10702-017-01


    Chlorphen-12
    Allergy

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

    3 in 1
    Fast Acting
    Long Lasting
    Less Drowsy


    100 Tablets

    Indoor & Outdoor Allergies
    12-hour Extended-Release Tablets
    Chlorpheniramine Maleate 12 mg/Antihistamine

    container label - 100s

  • Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets

    New Look. Same Trusted Ingredient. MADE IN USA
    NDC 10702-017-04

    NDC 10702-017-54

    Chlorphen-12
    Allergy

    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat

    3 in 1
    Fast Acting
    Long Lasting
    Less Drowsy

    4 Tablets in a sachet and a carton of 50 sachets

    Indoor & Outdoor Allergies
    12-hour Extended-Release Tablets
    Chlorpheniramine Maleate 12 mg/Antihistamine

    50 sachet carton

    4 tablets sachet

  • INGREDIENTS AND APPEARANCE
    CHLORPHEN-12 
    chlorpheniramine maleate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10702-017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE12 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GELATIN (UNII: 2G86QN327L)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code Chlorphen;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10702-017-0660 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2010
    2NDC:10702-017-2424 in 1 CARTON; Type 0: Not a Combination Product06/15/2010
    3NDC:10702-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2010
    4NDC:10702-017-5450 in 1 CARTON11/29/2018
    4NDC:10702-017-044 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04082906/15/2010
    Labeler - KVK-Tech, Inc. (173360061)
    Registrant - Avanthi, Inc. (832316694)
    Establishment
    NameAddressID/FEIBusiness Operations
    KVK-Tech, Inc.173360061manufacture(10702-017)
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