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
  • 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 January 1, 2023

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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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    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 finalpart34103/07/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
    Establishment
    NameAddressID/FEIBusiness Operations
    Llorens Pharmaceutical037342305manufacture(0485-0202)
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