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  5. Label Information: Dexbrompherniramine Maleate And Pseudoephedrine Sulfate 6mg/120mg

FDA Label for Dexbrompherniramine Maleate And Pseudoephedrine Sulfate 6mg/120mg

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRODUCT PACKAGING
    16. PRINCIPAL DISPLAY PANEL

Dexbrompherniramine Maleate And Pseudoephedrine Sulfate 6mg/120mg Product Label

The following document was submitted to the FDA by the labeler of this product Kvk-tech, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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 - figure 01 carton label

    carton label - figure 01 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.


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