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


Drug Facts

BIOGTUSS  - dextromethorphan hydrobromide, guaifenesin and phenylephrine 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 300 mg .............................................. Expectorant

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

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

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
  • May cause or aggravate constipation
  • 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 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 an MAOI;
ask your doctor or pharmacist before taking this product.

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

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.

Warning:Phenylketonuric. Contains 17 mg of Phenylalanine per 5 mL (one teaspoonful dose).

Inactive Ingredients aspartame, citric acid, D and C Red No 33, FD and C Blue No 1, glycerine, hydroxymethyl cellulose, methylparaben, natural and artificial flavors, propylene glycol, propylparaben, purified water, sodium citrate

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

BioGtussLabel


BIOGTUSS 
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-205(NDC:49523-471)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 300 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Water  
Methylparaben  
Propylparaben  
Propylene Glycol  
Sodium Citrate  
Citric Acid Monohydrate  
Aspartame  
D&C Red No. 33  
FD&C Blue No. 1  
Hydroxymethyl Cellulose  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (Grape Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45737-205-16 473 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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