OTC Medication Information: G-BRONCO-D

G-BRONCO-D- guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride suspension
MCLAREN MEDICAL INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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.

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

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

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.

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.

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.

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.

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
(click image for full-size original)
G-BRONCO-D
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43913-403
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
HYDROXYMETHYL CELLULOSE
METHYLPARABEN
POLYSORBATE 20
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SORBITAN MONOOLEATE
SORBITOL
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43913-403-16 474 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/01/2012
Labeler — MCLAREN MEDICAL INC (013770591)

Revised: 06/2015 MCLAREN MEDICAL INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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