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

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

    Close
  • ACTIVE INGREDIENT (IN EACH TABLET)

    Dexbrompheniramine maleate 6 mg

    Pseudoephedrine Sulfate 120 mg

    Close
  • 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
    Close
  • 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.

    Close
  • 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
    Close
  • ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

    • taking sedative or tranquilizers
    Close
  • 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
    Close
  • 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

    Close
  • IF PREGNANT OR BREAST-FEEDING

    ask a health professional before use.

    Close
  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Close
  • 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
    Close
  • 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

    Close
  • 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

    Close
  • INGREDIENTS AND APPEARANCE
    DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE  6MG/120MG
    dexbrompherniramine maleate and pseudoephedrine sulfate tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10702-005
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 6 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color GREEN Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code K;5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10702-005-21 2 in 1 CARTON 12/17/2018
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:10702-005-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078648 12/17/2018
    Labeler - KVK-TECH, INC. (173360061)
    Registrant - AVANTHI (832316694)
    Establishment
    Name Address ID/FEI Business Operations
    KVK-TECH, INC 173360061 MANUFACTURE(10702-005)
    Close