Aldex AN

Dosage form: tablet, chewable
Ingredients: DOXYLAMINE SUCCINATE 5mg
Labeler: Pernix Therapeutics, LLC
NDC Code: 65224-542

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 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

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

ALDEX AN 
doxylamine succinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-542
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore2 pieces
ShapeOVALSize10mm
FlavorORANGEImprint CodeAN
Contains    
Packaging
#Item CodePackage Description
1NDC:65224-542-01100 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/20/2010
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.

Hide
(web3)