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Aldex

Pernix Therapeutics, LLC

ALDEX GS™ Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each tablet) Purpose
Pseudoephedrine HCl 30mg Nasal Decongestant
Guaifenesin 190mg Expectorant

Aldex Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves
    • nasal congestion due to the common cold
    • promotes nasal and/or sinus drainage
    • restores freer breathing through the nose

Warnings

  • may cause excitability, or increased irritability especially in children
  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
  • trouble with urination due to enlargement of the prostate gland

Stop Use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222

Directions

  • take every 6 hours
  • take with a full glass of water
  • do not take more than 4 doses in 24 hours
Adults and children 12 years of age and older 2 tablets
Children 6 to under 12 years of age 1 tablet
Children under 6 years of age Ask a doctor

Other Information

store at controlled room temperature 20°-25°C (68°-77°F)

  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 65224-557-01

ALDEX GS™
Tablets

Decongestant/Expectorant

100 TABLETS

PERNIX
THERAPEUTICS

Aldex

Aldex

PSEUDOEPHEDRINE HYDROCHLORIDE and GUAIFENESIN TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65224-557
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg
Guaifenesin GUAIFENESIN 190 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Shape
WHITE 16 mm OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65224-557-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-03-21


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Be sure to consult your doctor before taking any medication!
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