Label: RYNEX DM- brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

  • NDC Code(s): 0485-0204-04, 0485-0204-16
  • 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 August 10, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Brompheniramine Maleate 1mg
    Dextromethorphan Hydrobromide 5 mg
    Phenylephrine Hydrochloride 2.5 mg

  • Purpose

    Antihistamine
    Antitussive
    Nasal Decongestant

  • Uses

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

    • runny nose
    • sneezing
    • itching of nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • 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 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
    • trouble urinating to to an enlarged prostate gland
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

    Adults and children

    12 years of age

    and older:






    		4 teaspoonfuls (20 mL)

    every 4 hours, not to

    exceed 24 teaspoonfuls

    in 24 hours.




    Children 6 to under

    12 years of age:






    		2 teaspoonfuls (10 mL)

    every 4 hours, not to

    exceed 12 teaspoonfuls

    in 24 hours.


    Children under

    6 years of age:





    		Consult a doctor

  • Other information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive ingredients

    Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

  • Questions? Comments?

    Call 1-800-543-9560

  • PRODUCT PACKAGING

    The packaging below represents the labeling currently used:



    Principal display panel and side panel for 473 mL label:



    NDC 00485-0204-16



    Rynex DM Liquid



    ANTIHISTAMINE ∙ ANTITUSSIVE

    NASAL DECONGESTANT



    Each 5 mL (one teaspoonful) for oral administration contains:

    Brompheniramine Maleate, USP..................1 mg

    Dextromethorphan HBr, USP.......................5 mg

    Phenylephrine HCl, USP...........................2.5 mg



    ALCOHOL FREE ∙ DYE FREE

    GLUTEN FREE ∙ SUGAR FREE



    ______________________________________________



    FOR PROFESSIONAL USE ONLY



    Tutti-Frutti Flavor



    Manufactured for:

    EDWARDS

    Pharmaceuticals, Inc.

    Ripley, MS 38663



    16 fl oz (473 mL)



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



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



    THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.



    The labeling for this product includes professional labeling which is not

    intended for use by the general public.



    Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663



    Iss. 01/12

    label

    backsample

  • INGREDIENTS AND APPEARANCE
    RYNEX  DM
    brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0204-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2011
    2NDC:0485-0204-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/14/2011
    Labeler - Edwards Pharmaceuticals, Inc (195118880)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!