Broncomar
FDA Label NDC 70242-103

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 (NDC 70242-103). 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 - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, 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 10 ml.)Purpose

Dextromethorphan Hydrobromide 30 mg ....................

Cough Suppressant

Guaifenesin 200 mg.......................................................

Expectorant

Otc - Purpose

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

Warnings

Do not exceed recommended dosage

Otc - Do Not Use


Do not use

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
  • If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
  • Avoid alcoholic beverage while taking this product.

    • Stop use and ask a doctor
    • 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 signserious condition.

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.

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.

Dosage & Administration

Directions

  • Do not exceed 6 doses in any 24 hour period.

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



Indications & Usage

Other Information:

  • Each 10 mls contains: sodium 4 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

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Glycerin, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

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 Maximun Cough Label (70242 103)

Broncomar Maximun Cough Label (70242 103)

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