BIOTPRES PEDIATRIC- dextromethorphan, guaifenesin, phenylephrine liquid

BioTPres by

Drug Labeling and Warnings

BioTPres by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PURPOSE

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

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

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

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients aspartame, citric acid,natural and artificial flavors, glycerine, methylparaben,natrosol, propylene glycol, propylparaben, purified water, sodium citrate

QUESTIONS

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOTPRES  PEDIATRIC
dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-227
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	75 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Aspartame (UNII: Z0H242BBR1)
Glycerin (UNII: PDC6A3C0OX)
Hydroxymethyl Cellulose (UNII: 273FM27VK1)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Orange Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-227-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

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)