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


Drug Facts

BRONCO-FLU PLUS - guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride and acetaminophen 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 10 mg....................................  Cough Suppressant


Phenylephrine Hydrochloride 5 mg.................................. Decongestant


Acetaminophen 320 mg...................................................Fever Reducer



Keep outer box for complete labeling including warnings.

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

For the temporary relief of minor aches and pains associated with:

  • headache
  • muscular ache
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps
  • the reduction of fever


Warnings

Do not exceed recommended dosage.If nervousness dizziness, or sleplessness occur, discontinue use and consult a doctor

  • A persistent cough may be a sign of a serious condition
  • If cough persists for more than 1 week (or symptoms do not improve with 7 days), tends to recur or is accompanied by a fever, rash or persistent headache, consult a doctor 
Liver toxicity may occur if

recommended dosage is exceeded
used with other products containing acetaminophen
used with moderate amounts of alcohol

Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

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) unless directed by a doctor
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
  • 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
  • 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 before taking this product.
  • with any other products containing acetaminophen
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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

Keep out of reach of children.

Directions:

(Adults and children under 12 years of age and older): Do not exceed 6 doses in 24 hours.


Children 6 to 12 years of age: Do not exceed 5 doses in 24 hours)

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

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


Children under 6 years of age:
Consult a doctor

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.





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






Distributed by : Turtle Chemicals

      6907 Turtle Bay Terrace

      Lake Worth, FL 33462

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

BroncoFluPlusLabel

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BRONCO-FLU  PLUS
guaifenesin, dextromethorphan, phenylephrine, acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-458
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
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 320 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
EDETATE DISODIUM  
FD&C RED NO. 40  
GLYCERIN  
PROPYLENE GLYCOL  
WATER  
SODIUM BENZOATE  
SODIUM CHLORIDE  
SACCHARIN SODIUM  
SORBITOL  
SUCRALOSE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14505-458-04 120 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/23/2009

Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharlmalab 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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