Medication Guide App

Aldex D

Dosage form: suspension
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL, PYRILAMINE MALEATE 16mg in 5mL
Labeler: Pernix Therapeutics, LLC
NDC Code: 65224-550

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® D

Drug Facts

Active ingredients (in each 5mL)Purpose
Pyrilamine Maleate 16 mgAntihistamine
Phenylephrine HCl 5 mgNasal Decongestant

Uses

temporarily relieves

  • runny nose

relieves

  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • nasal congestion due to the common cold

Warnings

  • may cause excitability, 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
  • glaucoma
  • a breathing problem such as emphysema, chronic bronchitis, or asthma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use
  • If you or your child are taking sedatives or tranquilizers

When using this product
  • Do not exceed recommended dosage.
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occurs
  • if symptoms do not improve within 7 days or are accompanied by fever.

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
  • do not take more than 4 doses in 24 hours or as directed by a doctor
Adults and children 12 years of age and older1 to 2 teaspoonsful
Children 6 to under 12 years of age1 teaspoonful
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

Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 65224-550-16

PERNIX
THERAPEUTICS

ALDEX® D

Antihistamine/Decongestant
(Pyrilamine/Phenylephrine)

Grape flavored suspension

Shake well

16 fl. oz. (473 mL)

ALDEX D 
phenylephrine hydrochloride and pyrilamine maleate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE16 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
GRAPE 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCROSE 
XANTHAN GUM 
TANNIC ACID 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65224-550-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2010
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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