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Drug Facts
G-bronco-d
FDA Label NDC 43913-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mclaren Medical Inc for the product G-bronco-d (NDC 43913-403). 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 other, otc - purpose, uses, warnings, otc - stop use, otc - ask doctor, otc - do not use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients (in each 5mL) | Purpose |
|---|---|
| Guaifenesin 200 mg | Expectorant |
| Dextromethorphan 10 mg | Antitussive |
| Phenylephrine 5 mg | Nasal 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 over | 2 teaspoons every 4 hours |
| Children 6 to under 12 years of age | 1 teaspoon every 4 hours |
| Children 2 to under 6 years of age | ½ teaspoon every 4 hours |
| Children under 2 years of age | Consult 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
Principal Display Panel (474 mL Bottle Label)
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