BRONCO-FLU DES- guaifenesin and dextromethorphan hydrobromide liquid 
Pharmalab Enterprises 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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Active Ingredients: (in each tsp. 5 mL)                  Purpose

Guaifenesin, USP 100 mg .............................................. Expectorant

Dextromethorphan Hydrobromide....................................  Cough Suppressant








Keep outer box for complete labeling including warnings.



Uses

Uses:

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus

Temporarily relieves nasal congestion and coughs due to minor throat and bronchial irritation occurring with the common cold

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

  • 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 a fever, rash or persistent headache, consult a doctor.

May cause or aggravate constipation

Do not use

  • For persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus)
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

Directions: (do not exceed 6 doses in 24 hours.)


Adults and children 12 years of age and over: 2 teaspoonsful (10 mL) every 4 hours

Children under 12 to 6 years of age: 1 teaspoonful (5 mL) every 4 hours

Children under 6 to 2 years of age:1/2 teaspoonful (2.5 mL) every 4 hours


Children under 2 years of age: Consult a doctor

Ask a doctor or pharmacist before use if you

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

Other information


Store at controlled room temperature: 15-30 C (59-86 F)


Tamper Evident Feature: Do not use if imprinted cello-band over cap is torn, broken, or missing.

Sodium: 10mg per 5 mL



Questions? Tel: 305-499-9404        8:00 AM- 5:00 PM Weekdays



Distributed by : Turtle Chemicals
                     6907 Turtle Bay Terrace,
                     Lake Worth, FL 33462

BroncoFluDesLabel

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BRONCO-FLU  DES
guaifenesin, dextromethorphan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-457
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SACCHARIN SODIUM 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY (Raspberry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:14505-457-04120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34112/23/2009
Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
NameAddressID/FEIBusiness Operations
Pharmalab Enterprises Inc.174401088manufacture

Revised: 08/2010
 
Pharmalab Enterprises Inc.