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


Drug Facts

BIOTPRES  - 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

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

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

Phenylephrine HCl 5 mg.................................. Decongestant

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

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 an MAOI;
ask your doctor or pharmacist before taking this product.

Do not Use

  • In a child under 2 years of age.

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)
  • cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product, do not exceed recommended dosage

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are 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 serous condition.

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 2 teaspoonful (10 mL) every 4 hours

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

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

children under 2 years of age ask doctor


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

Tamper evident by imprinted heat seal under cap. Do not use if there's evidence of tampering.

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

Inactive Ingredients aspartame, citric acid, Cherry Flavor, FD and C Red No 40, glycerine, methylparaben,natrosol, 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

BioTPresLabel


BIOTPRES 
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-225(NDC:49523-464)
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 200 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Water  
Methylparaben  
Propylparaben  
Propylene Glycol  
Sodium Citrate  
Citric Acid Monohydrate  
Aspartame  
FD&C RED NO. 40  
Hydroxymethyl Cellulose  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45737-225-16 473 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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