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VAZOBID-PD (Wraser Pharmaceuticals)

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LIQUID 118 mL in 1 BOTTLE (66992-490-04) Label Information

Complete VAZOBID-PD Information

  • ACTIVE INGREDIENT

    Active ingredients (in each 1 mL) contains: Purpose
    Brompheniramine Maleate 1.2 mg Antihistamine
    Phenylephrine HCI 2mg Decongestant

  • Uses:

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages.

  • Warnings:

    Do not exceed recommended dosage

    Do not use this product

    • 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 your 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 mellitus
    • difficulty in urination due to enlargement of the prostate gland

    Do not take this product if you are taking sedative or tranquilizers, without first consulting your doctor.

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
    • new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center Immediately. 1-800-222-1222


  • Directions:

    Do not exceed recommended dosage.

    Adults and children 12 years of age & over: 3mL every 4-6 hours, or as directed by a doctor.
    Children 6 to under 12 years of age: 1.5 mL every 4-6 hours, or as directed by a doctor.
    Children under 6 years of age: Consult a doctor

  • OTHER INFORMATION

    • store at 20°-25°C (68-77°F): F):excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]


  • Inactive ingredients:

    acesulfame, artificial bubble gum, aspartame, citric acid, FD&C Red #40, glycerin, methylparaben, neusilin, purified water, sodium benzoate, sodium citrate dehydrate, xanthan gum


  • Questions or Comments?

    Call weekdays from 9AM to 4PM CST at 1-888-252-3901 http://wraser.com email: medicalinfo@wraser.com

    Distributed by:
    WraSer Pharmaceuticals, LLC
    Ridgeland, MS 39157

    400768 Iss. 011/2011


  • PRINCIPAL DISPLAY PANEL

    Antihistamine Decongestant

    NDC 66992-490-04

    VAZOBID-PDâ„¢

    Brompheniramine Maleate 1.2 mg
    Phenylephrine HCI 2 mg

    Bubble Gum Flavored Suspension

    WraSer PHARMACEUTICALS

    Shake Well
    4 fl oz (118 mL)

    Patent Protected

    118 mL Container Label



  • INGREDIENTS AND APPEARANCE
    VAZOBID-PD 
    brompheniramine maleate and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66992-490
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1.2 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME (UNII: MA3UYZ6K1H)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM ALUMINOMETASILICATE TYPE I-A (UNII: 7LVU907546)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66992-490-04 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/01/2011
    Labeler - Wraser Pharmaceuticals (121828334)