Broncomar Expectorant
FDA Label NDC 70242-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Broncomar Expectorant (NDC 70242-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - ask doctor, ask a doctor before use, do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Broncomar Expectorant Sf (70242 100)

Broncomar Expectorant Sf (70242 100)

* Please review the disclaimer below.