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

Rynex by

Drug Labeling and Warnings

Rynex by is a Otc medication manufactured, distributed, or labeled by Edwards Pharmaceuticals, Inc, TG United, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RYNEX   DM
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0485-0204-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2011
2	NDC: 0485-0204-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/14/2011

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)

Establishment
Name	Address	ID/FEI	Business Operations
TG United, Inc.		172837085	manufacture(0485-0204)