Label:
DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG- dexbrompherniramine maleate and pseudoephedrine sulfa...
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  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information
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