RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]

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  • RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]

RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]
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NDC 0485-0206-16
Set ID 2f2d9b5a-f66b-4928-8d43-402ef9efcfdf
Category HUMAN OTC DRUG LABEL
Packager EDWARDS PHARMACEUTICALS, INC.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL teaspoonful)Purpose
    Brompheniramine Maleate 1 mgAntihistamine
    Pseudoephedrine HCI 15 mgDecongestant
  • 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

    On not exceed recommended dosage.

    Do not use this product

    • if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

    Do not use this product, unless directed by a doctor, if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • heart disease
    • thyroid disease
    • diabetes mellitus
    • difficulty in urination due to enlargement of the prostate gland

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

    When using this product

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

    Stop use and ask doctor If

    • nervousness, dizziness, or sleeplessness occur
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
    • new symptoms occur

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Do not exceed recommended dosage

    Adults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
    Children 6 to under 12 years of age:2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
    Children 2 to under 6 years of age1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours
    Children under 2 years of ageConsult a doctor
  • Other information

    Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

  • Inactive ingredients

    Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

  • Question? Comments?

    Call 1-800-543-9560

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 00485-0206-16

    Rynex PSE

    Antihistamine • Decongestant

    Sugar Free • Alcohol Free •
    Gluten Free

    Each teaspoonful (5 mL)
    for oral administration contains:
    Brompheniramine Maleate     1 mg
    Pseudoephedrine HCI           15 mg

    Orange Flavor
    FOR PROFESSIONAL USE ONLY

    This bottle is not to be
    dispensed to consumer.

    Tamper evident by foil seal under cap.
    Do not used foil seal is broken or missing.

    Dispense in a tight container with a child-
    resistant cap.

    Manufactured for:
    EDWARDS
    Pharmaceuticals, Inc.
    Ripley, MS 38663
    16oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    RYNEX PSE 
    brompheniramine maleate and pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0206
    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
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0206-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/07/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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