Rynex DM Liquid

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

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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
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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the 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 older:



4 teaspoonfuls (20 mL)
every 4 hours, not to
exceed 24 teaspoonfuls
in a 24 hour period, or as
directed by a doctor
Children 6 to under
12 years of age:



2 teaspoonfuls (10 mL)
every 4 hours, not to
exceed 12 teaspoonfuls
in a 24 hour period, or as
directed by a doctor
Children 2 to under
6 years of age:



1 teaspoonful (5 mL)
every 4 hours, not to
exceed 6 teaspoonfuls
in a 24 hour period, or
as directed by a doctor
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 00485-0204-16

Rynex DM Liquid

ANTIHISTAMINE / ANTITUSSIVE / 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


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 consumer.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

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

Iss. 01/11


Rynex DM Liquid Packaging



Rynex DM Liquid Packaging


RYNEX  DM
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10485-0204-16473 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/2011

Labeler - Edwards Pharmaceuticals, Inc. (195118880)
Revised: 03/2011Edwards Pharmaceuticals, Inc.