Pediatex TDM

Pernix Therapeutics, LLC

Pediatex TDM

FULL PRESCRIBING INFORMATION: CONTENTS*

• Pediatex TDM Uses
• Warnings
  • Do Not Use
  • When using this product
  • Overdose warning
• Directions
• Other Information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Pediatex TDM 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
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
  • the impulse to cough to help you get to sleep

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
• a persistent or chronic cough that occurs with too much phlegm (mucus)
• 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, rash, or headache. These could be signs of a serious condition.

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

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.

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 65224-537-30

PERNIX
THERAPEUTICS, LLC
Gonzales, LA 70737

Pediatex ^® TDM
1 fl. oz. (30 mL)

USE ONLY IF INDUCTION
SEAL IS STILL INTACT