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BioTPres

Advanced Generic Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

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

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

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

Purpose

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




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

Uses


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

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

BioTPres

BioTPres

Dextromethorphan, Guaifenesin, Phenylephrine LIQUID

Product Information

Product Type Human otc drug label 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 15 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
METHYLPARABEN
PROPYLPARABEN
propylene glycol
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
ASPARTAME
FD&C RED NO. 40
HYDROXYMETHYL CELLULOSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45737-225-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-01


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