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Name:Bronco-fludes
Manufacturer:Pharmalab Enterprises Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:14505-457
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
EDETATE DISODIUM  
FD&C RED NO. 40  
GLYCERIN  
WATER  
SODIUM BENZOATE  
SODIUM CHLORIDE  
SACCHARIN SODIUM  
SORBITOL  
SUCRALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY (Raspberry Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14505-457-04 120 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part341 12/23/2009

Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
Name Address ID/FEI Operations
Pharmalab Enterprises Inc. 174401088 manufacture

Revised: 08/2010 Pharmalab Enterprises Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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