FDA Label for G-bronco-d

View Indications, Usage & Precautions

G-bronco-d Product Label

The following document was submitted to the FDA by the labeler of this product Mclaren Medical 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.

Other



Drug Facts


Otc - Purpose



Active Ingredients (in each 5mL)Purpose
Guaifenesin 200 mgExpectorant
Dextromethorphan 10 mgAntitussive
Phenylephrine 5 mgNasal Decongestant

Uses



  • Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold
  • For the temporary relief of nasal congestion due to the common cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings



Do not exceed recommended dosage.


Otc - Stop Use



If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.


Otc - Ask Doctor



If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.


Otc - Do Not Use



Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.


Directions



  • Do not take more than 6 doses in any 24-hour period.
  • Adults and children 12 years of age and over2 teaspoons every 4 hours
    Children 6 to under 12 years of age1 teaspoon every 4 hours
    Children 2 to under 6 years of age½ teaspoon every 4 hours
    Children under 2 years of ageConsult a physician

Inactive Ingredients



Citric acid, flavor, hydroxymethylcellulose, methylparaben, polysorbate, propylene glycol, propylparaben, purified water, sorbitan monooleate, sorbitol and sucralose.


Other Information



Store at 20°-25°C (68°-77°F)

Do not refrigerate


Principal Display Panel - 474 Ml Bottle Label



NDC-43913-403-16

G-Bronco-D
Suspension

New Formula

Cough Suppressant • Expectorant • Decongestant
Sugar Free • Phenylalanine Free • Alcohol Free

Cherry Flavor

16 FL OZ (474 mL)

Multiple Dose Unit Package
For Dispensing Under Pharmaceutical Supervision Only

McLaren Medical


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