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Name:Bionel
Manufacturer:Advanced Generic Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BIONEL  - dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride liquid 
Advanced Generic Corporation

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 5 mL tsp.)              Purpose

Guaifenesin 200 mg .............................................. Expectorant

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Pseudoephedrine HCl 30 mg.................................. Nasal Decongestant

Uses
  • temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • temporary relief of cough due to minor throat and bronchial irritation
  • helps to control reflex that causes coughing

Warnings
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 you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.
Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

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

Directions Do not exceed 4 doses in 24 hours.

adults and children 12 years of age and over take 2 teaspoonful (10 mL) every 6 hours

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

children under 6 years of age  ask a doctor

Other information
  • store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
Warning: Phenylketonuric: Contains 19 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

Inactive ingredients aspartame, citric acid, glycerine, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

BionelLabel


BIONEL 
dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-206(NDC:49523-468)
Route of Administration ORAL DEA Schedule CI    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 200 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine ) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Water  
potassium citrate  
Potassium Sorbate  
Propylene Glycol  
propylparaben  
Citric Acid Monohydrate  
Aspartame  
methylparaben  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45737-206-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/01/2009

Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2010 Advanced Generic Corporation



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


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