Broncomar
FDA Label NDC 53113-216

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories Inc for the product Broncomar (NDC 53113-216). 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, indications & usage, warnings, otc - do not use, otc - stop 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

Acvtive ingredients: (in 10 ml)              Purpose

Dextromethorphan HBr 30 mg ................... Cough Suppressant

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

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Indications & Usage

Uses

  • Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
  • Teporarily 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 the MAOI drug.
  • if you do not know if your prescription drug contains on MAOI ask 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 beverages while you are taking this product

    • Ask the doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Stop Use

Stop use and ask the doctor if

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

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 take more than 6 doses in any 24-hour period

    • 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 tsps) every 4 hours

    Children under 6 years of age                       Do not use

Inactive Ingredient

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C Red #40, glycerin, hydroxyethyl cellulose, natural strawberry flavor, water, sodium benzoate, sorbitol 70%, sucralose

Package Label.Principal Display Panel

Broncomarmax (Broncomarmax)

Broncomarmax (Broncomarmax)

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