ED BRON GP- guaifenesin and phenylephrine liquid

ED BRON GP by

Drug Labeling and Warnings

ED BRON GP 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
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 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 passages
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

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.

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

Do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

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

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 of a serious condition.
• new symptoms occur

If pregnant or breastfeeding, 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: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 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

Citric Acid, Methyl Paraben, Orange Flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, and Sucralose.

Question? Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ED Bron GP Liquid

E

NDC: 0485-0208-16

ED Bron GP
Liquid

Expectorant Nasal Decongestant

Sugar Free Alcohol Free Dye Free

Each teaspoonful (5 mL)
for oral administration contains:
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

Orange Flavor

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)

INGREDIENTS AND APPEARANCE

ED BRON GP 
guaifenesin and phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0485-0208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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: 0485-0208-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2012

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)