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BioGtuss

Advanced Generic Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

Guaifenesin 388 mg .............................................. Expectorant

Dextromethorphan HBr 28 mg.................. Cough Suppressant

Phenylephrine HCl 10 mg...........................Nasal Decongestant

Purpose

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
  • temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.

Warnings

  • Do not exceed recommended dosage
  • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
  • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do Not Use

  • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
  • If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by a doctor.






If you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.

Keep out of reach of children.

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

Directions Do not exceed 6 doses in 24 hours.

adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 hours

children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 hours

children under 6 years of age  ask a doctor

Uses

Other information  store at room temperature 15°- 30°C (59° - 86°F).

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


Inactive Ingredients

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

BioGtuss

BioGtuss

Dextromethorphan, Guaifenesin, Phenylephrine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45737-242
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 28 mg
Guaifenesin GUAIFENESIN 388 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
water
METHYLPARABEN
PROPYLPARABEN
propylene glycol
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
polyethylene glycol
FD&C YELLOW NO. 6
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45737-242-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-09-01


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