Aldex CT description, usages, side effects, indications, overdosage, supplying and lots more!

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Aldex CT

Pernix Therapeutics, LLC

ALDEX-CT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each chewable tablet) Purpose
Diphenhydramine HCl 12.5 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant

Aldex CT 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

Aldex CT

Aldex CT

PHENYLEPHRINE HYDROCHLORIDE and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, CHEWABLE

Product Information

Product Type Human otc drug label 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 5 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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 Size Imprint Code Shape
BLUE 12 mm Zyber;MO12 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65224-545-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-01-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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