NASOPEN

Dosage form: liquid
Ingredients: Chlorcyclizine Hydrochloride 9.375mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: GM Pharmaceuticals, Inc.
NDC Code: 58809-578

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

PurposeAntihistamine
Nasal Decongestant

Usestemporarily 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 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

• 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 Do not exceed recommended dosage.

Adults and children 12 years of age and older:	2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in a 24 hour period.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period.
Children under 6 years of age:	consult a doctor

Other InformationStore at 59° to 86°F (15° to 30­°C).

Inactive IngredientsCitric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, and Sucralose.

Questions? Comments?Call 1-888-535-0305

Product PackagingThe 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.