NASOPEN

GM Pharmaceuticals, Inc
Pernix Manufacturing, LLC

NASOPEN PE

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• NASOPEN Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• NASOPEN Other information
• Inactive ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 15 mL (TBSP))
Phenylephrine HCl 10 mg
Thonzylamine HCl 50 mg

Purpose

Nasal Decongestant
Antihistamine

NASOPEN Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• nasal congestion
• reduces swelling of the nasal passages
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Do not use this product

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• use caution 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 accompanied by fever.
• new symptoms occur
  

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

·Do not exceed recommended dosage.
·Use enclosed dosage cup or tablespoon (TBSP).

NASOPEN Other information

·Each 15 mL (TBSP) contains: Sodium 7 mg.
·Store at 59° to 86°F (15° to 30°C).

Inactive ingredients

Cotton Candy Flavor, FD&C Red #40, Glycerin, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol, Sucralose.

Questions? Comments?

Call 1-888-535-0305

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 118 mL label:

NDC 58809-729-04

NASOPEN^® PE

Each 15 mL (TBSP) contains:
Phenylephrine HCl......................10 mg
Thonzylamine HCl......................50 mg

Nasal Decongestant · Antihistamine

Cotton Candy Flavor

Alcohol Free / Gluten Free
Sugar Free

4 fl. oz. (118 mL)

GM Pharmaceuticals, Inc.Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container
with a child-resistant cap.

Distributed by: GM Pharmaceuticals, Inc.
                          Arlington, Tx  76015

Iss. 10/11/13