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Bionel

Advanced Generic Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients: (in each 5 mL tsp.)              Purpose

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

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

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

Purpose

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

Uses

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: Inactive ingredients

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

Bionel

Bionel

Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45737-206
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Guaifenesin GUAIFENESIN 200 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
POTASSIUM CITRATE
POTASSIUM SORBATE
propylene glycol
PROPYLPARABEN
CITRIC ACID MONOHYDRATE
ASPARTAME
METHYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45737-206-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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