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Name:Aldexgs Dm
Manufacturer:Pernix Therapeutics, Llc
Category:Over-the-counter (OTC) Marketed Drugs


ALDEX GS™ DMTablets

ALDEX GS DM - pseudoephedrine hydrochloride, guaifenesin and dextromethorphan hydrobromide tablet 
Pernix Therapeutics, LLC

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.

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ALDEX GS DM
Tablets

Drug Facts

Active ingredients (in each tablet) Purpose
Dextromethorphan HBr 15mg Cough Suppressant
Pseudoephedrine HCl 30mg Nasal Decongestant
Guaifenesin 190mg Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
  • nasal congestion due to the common cold
  • promotes nasal and/or sinus drainage

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 65224-560-01

ALDEX GS DM
Tablets

Antitussive/Decongestant/
Expectorant

100 TABLETS

PERNIX
THERAPEUTICS

Principal Display Panel - 100 Tablet Bottle Label

ALDEX  GS DM
pseudoephedrine hydrochloride, guaifenesin, and dextromethorphan hydrobromide tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65224-560
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 190 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsule Shaped) Size 16mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65224-560-01 100 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/21/2011

Labeler - Pernix Therapeutics, LLC (004672296)

Revised: 03/2011 Pernix Therapeutics, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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