Label: RYNEX PE- brompheniramine maleate and phenylephrine hcl liquid

  • NDC Code(s): 0485-0202-16
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
      (in each 5 nil teaspoonful)     		Purpose
    Brompheniramine Maleate 1 mgAntihistamine
    Phenylephrine HCl 2.5 mgNasal 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 passage
  • Warnings

    Do not exceed recommended dosage.

    Do not take 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 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

    • 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

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

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • sedalives 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

    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.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children under 6 years of age:

    Consult a doctor
  • Other information

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

  • Inactive ingredients

    Bubblegum Flavor, Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

  • Questions Comments?

    Call 1-800-543-9560

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    Rynex PE

    E

    NDC 0485-0202-16

    Rynex PE

    Antihistamine • Nasal Decongestant

    Sugar Free • Alcohol Free

    • Gluten Free

    Each teaspoonful (5 mL)

    for oral administration contains:

    Brompheniramine Maleate 1 mg

    Phenylephrine HCl 2.5 mg

    Bubblegum Flavor

    FOR PROFESSIONAL USE ONLY

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or

    missing.

    Manufactured for:

    EDWARDS

    Pharmaceuticals, Inc.

    Ripley, MS 38663

    16oz. (473 mL)

    label

  • INGREDIENTS AND APPEARANCE
    RYNEX PE 
    brompheniramine maleate and phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0202-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/07/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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