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BioTPres Pediatric

Medically reviewed on December 19, 2017

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Guaifenesin 75mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Advanced Generic Corporation
NDC Code: 45737-227

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.

Drug Facts

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

Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant

Guaifenesin 75 mg .............................................. Expectorant

Phenylephrine HCl 2.5 mg.................................. Decongestant

Uses
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
  • 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 child has
  • 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 your child

  •  gets 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 4 teaspoonful (20 mL) every 4 hours

children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hours

children 2 to under 6 years of age take 1 teaspoonful (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 5 mg of Phenylalanine per 5 mL (one teaspoonful dose).

Inactive Ingredients aspartame, citric acid,natural and artificial flavors, 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

BIOTPRES  PEDIATRIC
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-227(NDC:49523-465)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin75 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Methylparaben 
Propylparaben 
Propylene Glycol 
Sodium Citrate 
Citric Acid Monohydrate 
Aspartame 
Glycerin 
Hydroxymethyl Cellulose 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45737-227-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2009
Labeler - Advanced Generic Corporation (831762971)

 
Advanced Generic Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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