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

G-BRONCO-D by

Drug Labeling and Warnings

G-BRONCO-D by is a Otc medication manufactured, distributed, or labeled by MCLAREN MEDICAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43913-403-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product

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)