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.

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G-BRONCO-D

Drug Facts

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

Uses

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

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

Principal Display Panel - 474 mL Bottle Label
G-BRONCO-D 
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-403
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43913-403-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2012
Labeler - MCLAREN MEDICAL INC (013770591)

Revised: 6/2015
Document Id: 509fb31b-09bb-4671-be8f-3dcf1771cbd3
Set id: 632d4219-7c36-4ed1-a5d0-7d0021b778a9
Version: 1
Effective Time: 20150629
 
MCLAREN MEDICAL INC