RYNEX DM- brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Edwards Pharmaceuticals, Inc

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.

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Rynex DM Liquid

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:

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

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)

Revised: 8/2023
Document Id: 02940f28-7dcf-f7cd-e063-6294a90af857
Set id: 7be2c282-24ba-4f19-9b14-872d3f5746a7
Version: 11
Effective Time: 20230810
 
Edwards Pharmaceuticals, Inc