You are here: Home > Over-the-counter (OTC) Drugs > A > Aldex An (Pernix Therapeutics, Llc)

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


ALDEX® AN Antihistamine (Doxylamine succinate)

ALDEX AN - doxylamine succinate 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.

----------

ALDEX® AN
Antihistamine
(Doxylamine succinate)

Drug Facts

Active ingredients (in each chewable tablet)

Doxylamine succinate, 5 mg

Purpose

Antihistamine

Uses

  • temporarily relieves
  • runny nose
  • relieves
  • sneezing
  • itching of nose and throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

  • May cause excitability, especially in children

Ask a doctor before use if you or your child has

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use

  • if you or your child are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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 4-6 hours
  • do not take more than 6 doses in 24 hours or as directed by a doctor
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

artificial flavor enhancer, FD&C Red #40, FD&C yellow #10, F-Melt-C, magnesium aluminometasilicate, magnesium stearate, natural orange flavor, purified water, pyridoxine HCl, sodium starch glycolate, sucralose, talc, zytan (galloquinate)

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 65224-542-01

PERNIX
THERAPEUTICS, LLC.

ALDEX® AN
Antihistamine
(Doxylamine succinate)

Orange Flavored

Chewable Tablets

100 Count

Principal Display Panel - 100 Tablet Bottle Label

ALDEX AN 
doxylamine succinate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65224-542
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40  
D&C YELLOW NO. 10  
MAGNESIUM ALUMINOMETASILICATE TYPE I-A  
MAGNESIUM STEARATE  
ORANGE  
WATER  
PYRIDOXINE HYDROCHLORIDE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
SUCRALOSE  
TALC  
TANNIC ACID  
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL Size 10mm
Flavor ORANGE Imprint Code AN
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65224-542-01 100 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


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback