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  5. Label Information: Ed Bron Gp

FDA Label for Ed Bron Gp

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. DO NOT TAKE THIS PRODUCT, UNLESS DIRECTED BY A DOCTOR, IF YOU HAVE
    7. OTC - DO NOT USE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTION? COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Ed Bron Gp Product Label

The following document was submitted to the FDA by the labeler of this product Edwards Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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:

  • 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

Otc - Do Not Use



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.


Otc - Ask Doctor/Pharmacist



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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 01

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - ed bron 01


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