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


ALDEX®-CT

ALDEX CT - phenylephrine hydrochloride and diphenhydramine hydrochloride tablet, chewable 
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®-CT

Drug Facts

Active ingredients (in each chewable tablet) Purpose
Diphenhydramine HCl 12.5 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

  • you get nervous, dizzy, or sleepless
  • 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.

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 tablets
Children 6 to under 12 years of age 1/2 to 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

Calcium Phosphate, Corn Starch, Citric Acid Anhydrous Powder, Di-Pac FD&C Blue #2, Magnasweet, Magnesium Stearate NF, Mannitol, Methocel E10 M cr, Neusilin Grade UFL2, Purified Water, Sodium Sacharrin, Strawberry Flavor, Talc, Zytan (galloquinate)

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 65224-545-01

PERNIX
THERAPEUTICS, LLC

ALDEX®-CT

Antihistamine/Decongestant
(Diphenhydramine/Phenylephrine)

Strawberry Flavored
Chewable Tablet

100 count

Principal Display Panel - 100 Tablet Bottle Label

ALDEX CT 
phenylephrine hydrochloride and diphenhydramine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65224-545
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE  
STARCH, CORN  
ANHYDROUS CITRIC ACID  
SUCROSE  
FD&C BLUE NO. 2  
MAGNESIUM STEARATE  
MANNITOL  
WATER  
SACCHARIN SODIUM  
TALC  
TANNIC ACID  
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (Capsule Shaped) Size 12mm
Flavor STRAWBERRY Imprint Code Zyber;MO12
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65224-545-01 100 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 01/20/2010

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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