Label: DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG- dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release

  • NDC Code(s): 10702-005-03, 10702-005-21
  • Packager: KVK-TECH, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2017

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Dexbrompheniramine maleate 6 mg

    Pseudoephedrine Sulfate 120 mg

  • PURPOSE

    Antihistamine

    Nasal decongestant

    USES

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitis
    • helps decongest sinus openings and sinus passages
    • reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
    • temporarily alleviates the following symptoms due to hay fever (allergic rhinitis):
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy and watery eyes
  • WARNINGS

    Do not use If you are now taking a prescription monoamineoxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
  • ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

    • taking sedative or tranquilizers
  • WHEN USING THIS PRODUCT

    • do not use more than directed
    • 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
  • STOP USE AND ASK A DOCTOR IF

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    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 69 mg and sodium 0 mg
    • store between  20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • INACTIVE INGREDIENTS

    calcium sulfate, carnauba wax, colloidal silicon dioxide, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6 aluminum lake, gelatin, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, pregelatinized maize starch, propyl parahydroxy benzoate, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

    QUESTIONS

    call 1-215-579-1842

    PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    Dexbrompheniramine Maleate 6 mg

    and Pseudoephedrine Sulfate 120 mg

    Extended-release Tablets

    Antihistamine/Nasal Decongestant

    COLD & ALLERGY

    Maximum Strength

    • Nasal & Sinus Congestion
    • Runny Nose, Sneezing
    • Itchy, Watery Eyes

      12 Hour Sustained Relief

      20 EXTENDED-RELEASE TABLETS

      SAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE 6 mg AND PSEUDOEPHEDRINE SULFATE 120 mg IS TORN OR MISSING.

      Manufactured by KVK-TECH, INC.

      Newtown, PA18940 MADE IN USA

  • Principal Display Panel

    Carton Label

    Dexbrompheniramine Maleate 6 mg
    and Pseudoephedrine Sulfate 120 mg
    Extended-release Tablets

    Antihistamine/Nasal Decongestant

    COLD & ALLERGY

    Maximum Strength

    • Nasal & Sinus Congestion
    • Runny Nose, Sneezing
    • Itchy, Watery Eyes12 Hour Sustained Relief

    20 EXTENDED-RELEASE TABLETS

    carton label

    Container Label

    NDC 10702-005-03

    Dexbrompheniramine Maleate 6 mg
    and Pseudoephedrine Sulfate 120 mg
    Extended-release Tablets

    Antihistamine/Nasal Decongestant

    COLD & ALLERGY

    Maximum Strength

    • Nasal & Sinus Congestionunny Nose, Sneezing
    • Itchy, Watery Eyes12 Hour Sustained Relief

    30 EXTENDED-RELEASE TABLETS

    DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.

    container Label

  • INGREDIENTS AND APPEARANCE
    DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE  6MG/120MG
    dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10702-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE6 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code K;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10702-005-212 in 1 CARTON12/17/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:10702-005-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07864812/17/2018
    Labeler - KVK-TECH, INC. (173360061)
    Registrant - AVANTHI (832316694)
    Establishment
    NameAddressID/FEIBusiness Operations
    KVK-TECH, INC173360061MANUFACTURE(10702-005)
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