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

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Aldex D

Pernix Therapeutics, LLC

ALDEX D


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant

Aldex D 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)

Aldex D

Aldex D

PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE SUSPENSION

Product Information

Product Type Human otc drug label 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 5 mg
PYRILAMINE MALEATE PYRILAMINE 16 mg

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65224-550-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-06-01


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Be sure to consult your doctor before taking any medication!
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