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Entex T

WraSer Pharmaceuticals, LLC




FULL PRESCRIBING INFORMATION

Drug Facts

Guaifenesin, USP                             375 mg

Pseudoephedrine HCl, USP              60 mg

Guaifenesin, USP                               Expectorant

Pseudoephedrine HCl, USP             Nasal decongestant

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies (allergic rhinitis)
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by excessive phlegm (mucus)

do not exceed the recommended dosage

  • nervousness, dizziness, or sleeplessness occur.
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • Do not exceed 4 doses in a 24 hour period
  • Adults and children 12 years of age and over: 1 tablet every 4 hours.
  • Children 6 to under 12 years of age: 1/2 tablet every 4 hours.
  • store at 20°- 25°C (68°- 77°F)
  • tamper evident: do not use if foil seal under the cap is broken or missing.
  • contains 4 mg sodium in each tablet
  • contains less than 1 mg magnesium in each tablet

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and starch.

Call weekdays from 9 AM to 4 PM CST at 1-888-252-3901 or go to http://www.wraser.com

email:medicalinfo@wraser.com

Figure 1: 100 ct Label Rev. 10/2012

Entex T

Entex T

Guaifenesin and Pseudoephedrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66992-281
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 375 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
WHITE 18 mm 375 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66992-281-10 100 in 1 BOTTLE
2 NDC:66992-281-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-09-30


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