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


ALDEX® D

ALDEX D - phenylephrine hydrochloride and pyrilamine maleate suspension 
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® D

Drug Facts

Active ingredients (in each 5mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal 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 older 1 to 2 teaspoonsful
Children 6 to under 12 years of age 1 teaspoonful
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

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)

Principal Display Panel - 473 mL Bottle Label

ALDEX D 
phenylephrine hydrochloride and pyrilamine maleate suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65224-550
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 16 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65224-550-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/01/2010

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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