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

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Pediatex

Pernix Therapeutics, LLC

Pediatex TD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each mL) Purpose
Triprolidine HCl 0.938 mg Antihistamine
Pseudoephedrine HCl 10 mg Nasal decongestant

Questions?

Call 1-800-793-2145

Pediatex Uses

  • temporarily relieves
    • runny nose
  • relieves;
    • sneezing
    • itching of nose and 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 or your child are taking sedatives or tranquilizers, without first consulting your doctor
  • if you or your child 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

When using this product

  • do not use more than directed
  • marked 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
  • symptoms do not improve within 7 days or are accompanied by a fever

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

Overdose warning

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
  • do not give more than directed or exceed the recommended daily dosage
Adults and children 12 years of age and over 2.67 mL
Children 6 to under 12 years of age 1.33 mL
Children under 6 years of age Ask a Doctor

Pediatex 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 cotton candy flavor, bitter mask, citric acid, FD&C red #40, glycerin, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, Zytan (galloquinate), xanthan gum, xylitol

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 65224-539-30

PERNIX
THERAPEUTICS, LLC
Gonzales, LA 70737

Pediatex ® TD

1 fl. oz. (30 mL)

Caution: Law prohibits
dispensing without
a prescription.

USE ONLY IF INDUCTION
SEAL IS STILL INTACT

Patent Protected Rev. 06/10

Pediatex

Pediatex

TRIPROLIDINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65224-539
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
triprolidine hydrochloride TRIPROLIDINE 0.938 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 10 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
Magnesium Aluminometasilicate Type I-a
METHYLPARABEN
water
SODIUM CITRATE
Sucralose
TANNIC ACID
XANTHAN GUM
Xylitol

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:65224-539-30 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-20


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Be sure to consult your doctor before taking any medication!
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