NASOPEN

GM Pharmaceuticals, Inc.

NASOPEN

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
• If pregnant or breast-feeding,
• Keep out of reach of children.
• Directions
• Other Information
• Inactive Ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients
(in each 5 mL teaspoonful)
Chlorcyclizine Hydrochloride 9.375 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine
Nasal Decongestant

NASOPEN Uses

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

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

Warnings

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

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

Ask a doctor 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

Other Information

Store at 59° to 86°F (15° to 30­°C).

Inactive Ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, and 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 473 mL label:

NDC 58809-578-01

NASOPEN

Each 5 mL (one Teaspoonful) contains:
Chlorcyclizine HCl...................9.375 mg
Pseudoephedrine HCl...................30 mg

Antihistamine / Nasal Decongestant

Cotton Candy Flavor

Alcohol Free / Gluten Free
Sugar Free / Dye Free

16 fl. oz. (473 mL)

GM Pharmaceuticals, Inc.

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

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

This bottle is not to be dispensed to consumer.

Distributed by: GM Pharmaceuticals, Inc.
                          Arlington, Tx  76012

Patent Pending

Iss. 04/11