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NASOPEN

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

NASOPEN

Drug Facts

Active Ingredients
(in each 5 mL teaspoonful)

Chlorcyclizine Hydrochloride 9.375 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine
Nasal Decongestant

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 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 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



NASOPEN 
chlorcyclizine hydrochloride, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-578
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride9.375 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Sorbitol 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-578-01473 mL in 1 BOTTLE
2NDC:58809-578-0212 BOTTLE (BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/06/201102/28/2015
Labeler - GM Pharmaceuticals, Inc. (793000860)

Revised: 12/2013
 
GM Pharmaceuticals, Inc.

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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