RYNEX PSE- brompheniramine maleate and pseudoephedrine hydrochloride liquid

RYNEX PSE by

Drug Labeling and Warnings

RYNEX PSE by is a Otc medication manufactured, distributed, or labeled by EDWARDS PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 1 mg	Antihistamine
Pseudoephedrine HCI 15 mg	Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion 'reduces swelling of nasal passages

Warnings

On not exceed recommended dosage.

Do not use this product

• if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

Do not use this product, unless directed by a doctor, if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• heart disease
• thyroid disease
• diabetes mellitus
• difficulty in urination due to enlargement of the prostate gland

Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• alcohol, sedatives and tranquilizers may increase drowsiness effect
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

Stop use and ask doctor If

• nervousness, dizziness, or sleeplessness occur
• If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
• new symptoms occur

Keep out of 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 over: 4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
• Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
• Children 2 to under 6 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours
• Children under 2 years of age: Consult a doctor

Other information

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Inactive ingredients

Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 00485-0206-16

Rynex PSE

Antihistamine Decongestant

Sugar Free Alcohol Free

Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Brompheniramine Maleate 1 mg

Pseudoephedrine HCI 15 mg

Orange Flavor

FOR PROFESSIONAL USE ONLY

This bottle is not to be

dispensed to consumer.

Tamper evident by foil seal under cap.

Do not used foil seal is broken or missing.

Dispense in a tight container with a child-

resistant cap.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

INGREDIENTS AND APPEARANCE

RYNEX PSE 
brompheniramine maleate and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0485-0206
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0485-0206-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/07/2011

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)