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:

• 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 mellitus
  

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 drowsiness
• 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.  These could be signs or 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 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 brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0485-0204 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 1 mg  in 5 mL Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 5 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2.5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Citric Acid   Glycerin   Propylene Glycol   Water   Sodium Citrate   Saccharin Sodium   Sorbitol

Product Characteristics Color      Score      Shape Size Flavor TUTTI FRUTTI Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0485-0204-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/14/2011

Labeler - Edwards Pharmaceuticals, Inc. (195118880)

Revised: 03/2011Edwards Pharmaceuticals, Inc.