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Rynex DM

Dosage form: liquid
Ingredients: Brompheniramine Maleate 1mg in 5mL, Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Edwards Pharmaceuticals, Inc.
NDC Code: 0485-0204

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.

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:

  • 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 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 2 to under
6 years of age:



1 teaspoonful (5 mL)
every 4 hours, not to
exceed 6 teaspoonfuls
in 24 hours.

Children Under 2:
Consult a Physician

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 0485-0204-16

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 by:  Great Southern Laboratories, Houston, TX  77099

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

Iss. 02/13

RYNEX  DM
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate1 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium Dihydrate 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0485-0204-16473 mL in 1 BOTTLE
2NDC:0485-0204-1010 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/2011
Labeler - Edwards Pharmaceuticals, Inc. (195118880)

Revised: 04/2013
 
Edwards Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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