Aldex GS

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg, GUAIFENESIN 190mg
Labeler: Pernix Therapeutics, LLC
NDC Code: 65224-557

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.

ALDEX GS™
Tablets

Drug Facts

Active ingredients (in each tablet)Purpose
Pseudoephedrine HCl 30mgNasal Decongestant
Guaifenesin 190mgExpectorant

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 older2 tablets
Children 6 to under 12 years of age1 tablet
Children under 6 years of ageAsk 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  GS
pseudoephedrine hydrochloride and guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-557
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN190 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Capsule Shaped) Size16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65224-557-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/21/2011
Labeler - Pernix Therapeutics, LLC (004672296)

Revised: 03/2011
 
Pernix Therapeutics, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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