Drug Facts

Active Ingredients (in each 5 nil teaspoonful)	Purpose
Brompheniramine Maleate 1 mg	Antihistamine
Phenylephrine HCl 2.5 mg	Nasal 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 passage

Warnings

Do not exceed recommended dosage.

Do not take 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 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
heart disease
high blood pressure
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product

excitability may occur, especially in children
may cause drowsiness
sedalives 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

If pregnant or breast feeding, ask a health professional before use.

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 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor

Other information

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

Inactive ingredients

Bubblegum Flavor, Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

Questions Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Rynex PE

NDC 0485-0202-16

Rynex PE

Antihistamine • Nasal Decongestant

Sugar Free • Alcohol Free

• Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Brompheniramine Maleate 1 mg

Phenylephrine HCl 2.5 mg

Bubblegum Flavor

FOR PROFESSIONAL USE ONLY

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or

missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

label

RYNEX PE
brompheniramine maleate and phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0485-0202
Route of Administration	ORAL

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

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

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0485-0202-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	03/07/2011

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

ED-RynexPE 0202