ED BRON GP- guaifenesin and phenylephrine liquid 
EDWARDS PHARMACEUTICALS, INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ED BRON GP

Drug Facts

Active Ingredients
(in each 5 mL teaspoonful) 		Purpose
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 5 mgNasal Decongestant

Uses

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

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)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
ED BRON GP 
guaifenesin and phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0208-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2012
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 1/2024
Document Id: 0ed91d53-2c7a-1a17-e063-6294a90a9d65
Set id: b1fca5aa-d877-45e0-b074-dcbc6af94ee3
Version: 6
Effective Time: 20240113
 
EDWARDS PHARMACEUTICALS, INC.