Label: Q-TAPP DM ELIXIR- brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide elixir

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 10, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL = 1 tsp)

    Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL = 1 tsp)

    Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL = 1 tsp)

  • PURPOSE

    Purpose of Brompheniramine maleate: Antihistamine

    Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

    Purpose of Dextromethorphan hydrobromide: Cough Suppressant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
    • temporarily relieves symptoms due to hay fever (allergic rhinitis):
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
      • temporarily restores freer breathing through the nose
  • Warnings

    Do not use in children under 6 years of age

    Do not use if you are now taking a prescription monoamine oxidase 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsines
    •  be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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

    • do not take more than 4 doses in any 24-hour

    Adults and children 12 years and over
    		20 mL (4 tsp) every 4 to 6 hours
    Children 6 years to under 12 years
    		10 mL (2 tsp) every 4 to 6 hours
    Children under 6 yearsDO NOT USE
    Other information
    • each tsp contains: sodium 2 mg
    • Store at room temperature 20°-25°C (68°-77°F).
  • Inactive ingredients

    citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.

  • Questions

    Made in USA
    for Qualitest Pharmaceuticals
    130 Vintage Drive
    Huntsville, AL 35811
  • PRINCIPAL DISPLAY PANEL



    container label
  • INGREDIENTS AND APPEARANCE
    Q-TAPP DM ELIXIR  
    brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0852(NDC:0603-0864)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Brompheniramine maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine maleate1 mg  in 5 mL
    Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine hydrochloride15 mg  in 5 mL
    Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-0852-0118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/05/2001
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc791119022repack
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