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  5. Label Information: Broncomar SF

FDA Label for Broncomar SF

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broncomar SF Product Label

The following document was submitted to the FDA by the labeler of this product Gadal Laboratories 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.

Otc - Active Ingredient



Acvtive ingredients: (in each 5ml)              Purpose

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


Otc - Purpose



Purpose

Expectorant


Indications & Usage



Uses

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

Warnings



Warnings

Do not exceed recommended dosage


Otc - Do Not Use



Do not use

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

    • 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
  • 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 tsps) every 4 hours

    Children under 6 years of age                       Do not use


Inactive Ingredient



Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.


Package Label.Principal Display Panel



BroncomarSF - BroncomarSF

BroncomarSF - BroncomarSF


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