FDA Label for Broncomar Expectorant SF

View Indications, Usage & Precautions

Broncomar Expectorant SF Product Label

The following document was submitted to the FDA by the labeler of this product Dannso Corp./d.b.a. Essential Products. 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.

Otc - Active Ingredient



Active Ingredients:(in each 5 ml.)Purpose

Guaifenesin 100 mg.......................................................

Expectorant


Otc - Purpose



Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

Warnings



Warnings

Do not exceed recommended dosage


Otc - Ask Doctor



Ask doctor before use if you have

  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask A Doctor Before Use



  • Nervousness, dizziness or sleeplessness occurs.
  • Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be sign serious condition.

Do Not Use



  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

Otc - Pregnancy Or Breast Feeding



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



Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Avoid alcoholic beverages while using this product.


Dosage & Administration



Directions

  • Do not exceed 6 doses in any 24 hour period.
  • Shake well before use

  • AGE
    DOSE
    Adults and Children 12 years and over
    10 ml (2 tsps) every 4 hours
    Children 6 to under 12 years of age
    5 ml (1 tsp) every 4 hours
    Children under 6 years of age
    Do not  use

Indications & Usage



Other Information:

  • Each 5 mls contains: sodium 8 mg
  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient



Blue Cohosh, Citric Acid, Echinacea Oil, Ginkgo Biloba, Glycerin Seal Root, Honey Flavor, Horehound Herb, Licorice, Golden Seal Root, Menthol, Mullein, Myrrh, Potassium Sobate, Slippery Elm Bark, Sodium Benzoate, Propylene Glycol, Purifed Water, sodium Chloride, Sucralose, Wild Cheery bark, and Zinc Sulfate.


Questions Or Comments



Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.


Package Label.Principal Display Panel




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