Q-TAPP DM ELIXIR (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) ELIXIR [PREFERRED PHARMACEUTICALS, INC]

Q-TAPP DM ELIXIR (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) ELIXIR [PREFERRED PHARMACEUTICALS, INC]
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NDC 68788-0852-0
Set ID 0654b093-2067-492f-a0bc-647dac430bde
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals, Inc
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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  • PURPOSE

    Purpose of Brompheniramine maleate: Antihistamine

    Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

    Purpose of Dextromethorphan hydrobromide: Cough Suppressant

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  • 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
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  • 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.

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  • 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 years DO NOT USE
    Other information
    • each tsp contains: sodium 2 mg
    • Store at room temperature 20°-25°C (68°-77°F).
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  • 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.

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  • Questions

    Made in USA
    for Qualitest Pharmaceuticals
    130 Vintage Drive
    Huntsville, AL 35811
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  • INGREDIENTS AND APPEARANCE
    Q-TAPP DM ELIXIR  
    brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide elixir
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0852(NDC:0603-0864)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Brompheniramine maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine maleate 1 mg  in 5 mL
    Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine hydrochloride 15 mg  in 5 mL
    Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor GRAPE (grape flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-0852-0 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/05/2001
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc 791119022 repack
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